Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 1:48 AM
Study NCT ID:
NCT00970593
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2009-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data for fasting Insulin level abnormalities and capillary glucose level abnormalities was not reported due to change in planned analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vomiting projectile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Infusion site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Polydipsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Umbilical erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Physical Examination Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': "Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) \\>=160 millimeter of mercury (mmHg), (less than equal to) \\<=90 mmHg, \\>=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of \\>=100 mmHg, \\<=50 mmHg, \\>=15 mmHg increase and decrease from baseline; heart rate of \\>=120 beats per minute (bpm), \\<=45 bpm, (greater than) \\>15 bpm increase and decrease from baseline, orthostatic SBP: decrease of \\>=20 mm Hg from sitting value, orthostatic DBP: decrease of \\>=20 mm Hg from sitting value, orthostatic heart rate: increase of \\>=30 bpm from sitting value, oral temperature of (less than) \\<35 or \\>38.3 degree celsius, respiratory rate of \\<10 or \\>25 breaths per minute, weight: maximum increase or decrease of \\>=7 percent (%) from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for clinically significant ECG abnormalities: PR interval \\>=220 millisecond (msec) or a change of \\>=20 msec from baseline values, QRS interval \\>=120 msec, QTc interval \\>450 msec (in males) and \\>470 msec (in females).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'N' (Number of Participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Hematocrit, haemoglobin: decrease of \\>=0.05 L/L and \\>=20 g/L from baseline respectively, WBC count:\\<3\\*10\\^9 /L, neutrophils: \\<1.5\\*10\\^9 /L, platelet count: \\<100\\*10\\^9 /L, eosinophil: \\<0.5\\*10\\^9 /L; prothrombin time, partial thromboplastin time \\>1.5\\*upper limit of normal (ULN); sodium:\\>5 mmol/L above ULN or below lower limit of normal(LLN), potassium \\>0.5 mmol/L above ULN or below LLN, creatinine \\>1.36\\*ULN, blood urea nitrogen \\>1.5\\*ULN, glucose (fasting) \\>0.83 mmol/L above ULN or below LLN, glucose (non-fasting) \\>5 mmol/L above ULN or \\>0.56 below LLN, calcium, magnesium: Change of \\>=0.25 and \\>=0.21 mmol/L from baseline respectively, phosphorus \\>0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of \\>=20g/L, \\>=10 g/L, \\>0.119 mmol/L from baseline respectively, creatinine kinase \\>3\\*ULN, total cholesterol \\>7.77 mmol/L, triglycerides \\>3.39 mmol/L: AST, ALT, total bilirubin \\>2\\*ULN, alkaline phosphatase \\>1.5\\*ULN, alpha-glumatyl transferase, lactate dehydrogenase \\>3\\*ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Irritation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Inflammation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Injection site reactions included irritation, erythema, pain, hematoma, inflammation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria: Blood glucose levels \\>15 milligram per deciliter (mg/dL) above ULN or \\>15 mg/dL below LLN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually \\<=50 mg/dL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Drug-Induced Liver Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be \\>= 3 times ULN concurrent with a total bilirubin of \\>=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be \\<=2 times ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Predose Fasting Glucose Levels at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.02', 'spread': '2.373', 'groupId': 'OG000'}, {'value': '10.06', 'spread': '2.583', 'groupId': 'OG001'}, {'value': '9.27', 'spread': '2.148', 'groupId': 'OG002'}, {'value': '9.01', 'spread': '1.769', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.37', 'spread': '2.222', 'groupId': 'OG000'}, {'value': '-2.75', 'spread': '1.663', 'groupId': 'OG001'}, {'value': '-2.47', 'spread': '1.400', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '1.166', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.526', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.90', 'ciLowerLimit': '-2.98', 'ciUpperLimit': '-0.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.543', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.15', 'ciLowerLimit': '-3.06', 'ciUpperLimit': '-1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.458', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8', 'description': 'Fasting glucose levels were determined before administration of OAP-189 using a glucometer.', 'unitOfMeasure': 'millimole per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR and Placebo IR as pre-specified in the protocol."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Predose Fasting Glucose Levels at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG003', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.62', 'spread': '0.998', 'groupId': 'OG000'}, {'value': '-3.87', 'spread': '1.783', 'groupId': 'OG001'}, {'value': '-3.49', 'spread': '1.643', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '1.273', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.37', 'ciLowerLimit': '-3.52', 'ciUpperLimit': '-1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.580', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.18', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '-2.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.495', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.14', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '-2.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.437', 'groupDescription': 'The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15', 'description': 'Fasting glucose levels were determined before administration of OAP-189 using a glucometer.', 'unitOfMeasure': 'millimole per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this measure. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR and Placebo IR as pre-specified in protocol."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '318.7', 'spread': '140.36', 'groupId': 'OG000'}, {'value': '455.6', 'spread': '246.43', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dose', 'categories': [{'measurements': [{'value': '899.1', 'spread': '344.02', 'groupId': 'OG000'}, {'value': '990.9', 'spread': '453.01', 'groupId': 'OG001'}]}]}, {'title': '2 hour post dose', 'categories': [{'measurements': [{'value': '885.4', 'spread': '364.20', 'groupId': 'OG000'}, {'value': '1112', 'spread': '652.61', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dose', 'categories': [{'measurements': [{'value': '881.4', 'spread': '357.83', 'groupId': 'OG000'}, {'value': '1063', 'spread': '613.86', 'groupId': 'OG001'}]}]}, {'title': '4 hour post dose', 'categories': [{'measurements': [{'value': '912.3', 'spread': '381.22', 'groupId': 'OG000'}, {'value': '943.7', 'spread': '474.35', 'groupId': 'OG001'}]}]}, {'title': '6 hour post dose', 'categories': [{'measurements': [{'value': '869.7', 'spread': '215.27', 'groupId': 'OG000'}, {'value': '804.8', 'spread': '349.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =2 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) analysis set. Here, 'N' (Number of Participants analyzed) signifies those participants who were evaluable for this measure. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR, Placebo IR, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '544.7', 'spread': '334.72', 'groupId': 'OG000'}, {'value': '558.9', 'spread': '386.19', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dose', 'categories': [{'measurements': [{'value': '998.8', 'spread': '360.42', 'groupId': 'OG000'}, {'value': '1276', 'spread': '858.80', 'groupId': 'OG001'}]}]}, {'title': '2 hour post dose', 'categories': [{'measurements': [{'value': '980.7', 'spread': '336.37', 'groupId': 'OG000'}, {'value': '1084', 'spread': '582.26', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dose', 'categories': [{'measurements': [{'value': '995.8', 'spread': '342.21', 'groupId': 'OG000'}, {'value': '985.5', 'spread': '424.50', 'groupId': 'OG001'}]}]}, {'title': '4 hour post dose', 'categories': [{'measurements': [{'value': '938.3', 'spread': '355.38', 'groupId': 'OG000'}, {'value': '974.7', 'spread': '504.81', 'groupId': 'OG001'}]}]}, {'title': '6 hour post dose', 'categories': [{'measurements': [{'value': '804.6', 'spread': '343.23', 'groupId': 'OG000'}, {'value': '854.0', 'spread': '415.21', 'groupId': 'OG001'}]}]}, {'title': '8 hour post dose', 'categories': [{'measurements': [{'value': '617.0', 'spread': '265.18', 'groupId': 'OG000'}, {'value': '735.4', 'spread': '350.03', 'groupId': 'OG001'}]}]}, {'title': '10 hour post dose', 'categories': [{'measurements': [{'value': '462.4', 'spread': '194.50', 'groupId': 'OG000'}, {'value': '658.1', 'spread': '457.83', 'groupId': 'OG001'}]}]}, {'title': '12 hour post dose', 'categories': [{'measurements': [{'value': '987.2', 'spread': '442.22', 'groupId': 'OG000'}, {'value': '1029', 'spread': '477.30', 'groupId': 'OG001'}]}]}, {'title': '14 hour post dose', 'categories': [{'measurements': [{'value': '972.6', 'spread': '415.05', 'groupId': 'OG000'}, {'value': '976.4', 'spread': '497.10', 'groupId': 'OG001'}]}]}, {'title': '16 hour post dose', 'categories': [{'measurements': [{'value': '889.7', 'spread': '465.26', 'groupId': 'OG000'}, {'value': '906.1', 'spread': '418.88', 'groupId': 'OG001'}]}]}, {'title': '24 hour post dose', 'categories': [{'measurements': [{'value': '455.1', 'spread': '488.53', 'groupId': 'OG000'}, {'value': '503.5', 'spread': '334.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =2 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set. Here, 'N' = participants evaluable for this measure. This outcome was not to be analyzed in participants of Placebo IR, OAP-189 MR (0.05:1 Z/P ratio) 0.9 mg followed by 1.2 mg, OAP-189 MR (0.1:1 Z/P ratio) 1.2 mg followed by 1.6 mg, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Concentration Versus Time Summary of Single Dose of OAP-189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG002', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Day 7: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.173', 'spread': '0.55480', 'groupId': 'OG000'}, {'value': '3.253', 'spread': '1.2371', 'groupId': 'OG001'}, {'value': '2.313', 'spread': '1.0927', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: 2 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.065', 'spread': '2.8023', 'groupId': 'OG000'}, {'value': '11.56', 'spread': '8.9549', 'groupId': 'OG001'}, {'value': '5.380', 'spread': '3.2235', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: 4 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.40', 'spread': '4.8907', 'groupId': 'OG000'}, {'value': '14.21', 'spread': '10.429', 'groupId': 'OG001'}, {'value': '6.113', 'spread': '2.8196', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: 6 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.173', 'spread': '4.4176', 'groupId': 'OG000'}, {'value': '11.71', 'spread': '6.7732', 'groupId': 'OG001'}, {'value': '5.249', 'spread': '2.7225', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.350', 'spread': '0.85499', 'groupId': 'OG000'}, {'value': '4.550', 'spread': '2.0888', 'groupId': 'OG001'}, {'value': '3.404', 'spread': '1.6691', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 1 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.740', 'spread': '3.4367', 'groupId': 'OG000'}, {'value': '18.46', 'spread': '34.903', 'groupId': 'OG001'}, {'value': '7.686', 'spread': '5.0265', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 2 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.747', 'spread': '4.8634', 'groupId': 'OG000'}, {'value': '19.53', 'spread': '23.410', 'groupId': 'OG001'}, {'value': '8.492', 'spread': '4.0211', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 3 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.23', 'spread': '4.4618', 'groupId': 'OG000'}, {'value': '19.79', 'spread': '17.035', 'groupId': 'OG001'}, {'value': '8.969', 'spread': '3.6809', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 4 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.70', 'spread': '4.4452', 'groupId': 'OG000'}, {'value': '17.88', 'spread': '12.785', 'groupId': 'OG001'}, {'value': '8.911', 'spread': '3.5977', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 6 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.611', 'spread': '3.7471', 'groupId': 'OG000'}, {'value': '14.97', 'spread': '10.234', 'groupId': 'OG001'}, {'value': '7.353', 'spread': '3.2211', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 8 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.094', 'spread': '3.3158', 'groupId': 'OG000'}, {'value': '12.83', 'spread': '7.6125', 'groupId': 'OG001'}, {'value': '6.326', 'spread': '2.7418', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 10 hour post dose (', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.991', 'spread': '2.6902', 'groupId': 'OG000'}, {'value': '10.13', 'spread': '5.8597', 'groupId': 'OG001'}, {'value': '5.845', 'spread': '2.1174', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 12 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.431', 'spread': '2.0067', 'groupId': 'OG000'}, {'value': '7.939', 'spread': '4.6575', 'groupId': 'OG001'}, {'value': '5.152', 'spread': '2.3713', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 14 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.341', 'spread': '1.5433', 'groupId': 'OG000'}, {'value': '6.708', 'spread': '3.4394', 'groupId': 'OG001'}, {'value': '4.604', 'spread': '1.7001', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 16 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.160', 'spread': '0.93113', 'groupId': 'OG000'}, {'value': '5.993', 'spread': '3.0649', 'groupId': 'OG001'}, {'value': '4.612', 'spread': '1.8386', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 24 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.910', 'spread': '0.70512', 'groupId': 'OG000'}, {'value': '3.911', 'spread': '1.7983', 'groupId': 'OG001'}, {'value': '3.688', 'spread': '1.2721', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 48 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.285', 'spread': '0.29853', 'groupId': 'OG000'}, {'value': '1.781', 'spread': '1.1929', 'groupId': 'OG001'}, {'value': '1.968', 'spread': '1.1127', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: 72 hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4900', 'spread': '0.43025', 'groupId': 'OG000'}, {'value': '1.070', 'spread': '1.5187', 'groupId': 'OG001'}, {'value': '0.8378', 'spread': '0.72049', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (2 hours before dosing), 2, 4, 6 hours post-dose on Day 7; Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72 hours post-dose on Day 14', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ = 0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set. Here, 'n' signifies those participants who were evaluable at specified time points. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR, Placebo IR and MR as pre-specified in protocol."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Concentration Versus Time Summary of Multiple Dose of OAP-189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'OG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '1.667', 'spread': '1.4404', 'groupId': 'OG000'}, {'value': '3.548', 'spread': '1.9612', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dose', 'categories': [{'measurements': [{'value': '2.727', 'spread': '1.4936', 'groupId': 'OG000'}, {'value': '4.920', 'spread': '1.7474', 'groupId': 'OG001'}]}]}, {'title': '2 hour post dose', 'categories': [{'measurements': [{'value': '4.454', 'spread': '2.9789', 'groupId': 'OG000'}, {'value': '7.824', 'spread': '2.9187', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dose', 'categories': [{'measurements': [{'value': '5.614', 'spread': '3.0258', 'groupId': 'OG000'}, {'value': '10.09', 'spread': '3.9267', 'groupId': 'OG001'}]}]}, {'title': '4 hour post dose', 'categories': [{'measurements': [{'value': '6.080', 'spread': '3.0045', 'groupId': 'OG000'}, {'value': '11.79', 'spread': '5.0857', 'groupId': 'OG001'}]}]}, {'title': '6 hour post dose', 'categories': [{'measurements': [{'value': '5.206', 'spread': '2.0969', 'groupId': 'OG000'}, {'value': '9.204', 'spread': '4.3138', 'groupId': 'OG001'}]}]}, {'title': '8 hour post dose', 'categories': [{'measurements': [{'value': '4.064', 'spread': '1.6576', 'groupId': 'OG000'}, {'value': '6.889', 'spread': '2.7902', 'groupId': 'OG001'}]}]}, {'title': '10 hour post dose', 'categories': [{'measurements': [{'value': '2.743', 'spread': '1.0067', 'groupId': 'OG000'}, {'value': '5.076', 'spread': '2.0844', 'groupId': 'OG001'}]}]}, {'title': '12 hour post dose', 'categories': [{'measurements': [{'value': '5.315', 'spread': '2.0278', 'groupId': 'OG000'}, {'value': '9.376', 'spread': '3.7875', 'groupId': 'OG001'}]}]}, {'title': '14 hour post dose', 'categories': [{'measurements': [{'value': '6.976', 'spread': '2.7327', 'groupId': 'OG000'}, {'value': '11.61', 'spread': '6.2016', 'groupId': 'OG001'}]}]}, {'title': '16 hour post dose', 'categories': [{'measurements': [{'value': '6.157', 'spread': '1.8865', 'groupId': 'OG000'}, {'value': '10.87', 'spread': '4.9706', 'groupId': 'OG001'}]}]}, {'title': '24 hour post dose', 'categories': [{'measurements': [{'value': '1.315', 'spread': '0.87065', 'groupId': 'OG000'}, {'value': '2.591', 'spread': '1.3243', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set. Here, 'N' = participants evaluable for this measure. This outcome was not to be analyzed in participants of Placebo IR, OAP-189 MR (0.05:1 Z/P ratio) 0.9 mg followed by 1.2 mg, OAP-189 MR (0.1:1 Z/P ratio) 1.2 mg followed by 1.6 mg, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'FG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Discontinuation of study by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All participants received the background metformin immediate release tablets, during the 4 weeks run-in period. Compliant participants were then randomized to study treatments for a maximum period of 31 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '92', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'OAP-189 0.2 mg IR', 'description': 'Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG001', 'title': 'OAP-189 0.4 mg IR', 'description': 'Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG002', 'title': 'OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg', 'description': 'Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide \\[Z/P\\] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG003', 'title': 'OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG004', 'title': 'OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg', 'description': 'Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG005', 'title': 'Placebo IR', 'description': 'Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG006', 'title': 'Placebo MR', 'description': 'Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization).'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.00', 'spread': '8.65', 'groupId': 'BG000'}, {'value': '53.60', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '52.69', 'spread': '3.12', 'groupId': 'BG002'}, {'value': '54.92', 'spread': '6.69', 'groupId': 'BG003'}, {'value': '51.50', 'spread': '9.64', 'groupId': 'BG004'}, {'value': '53.80', 'spread': '9.34', 'groupId': 'BG005'}, {'value': '54.75', 'spread': '6.83', 'groupId': 'BG006'}, {'value': '53.57', 'spread': '7.33', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all randomly assigned participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2009-09-01', 'resultsFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-28', 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =2 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.'}, {'measure': 'Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =2 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.'}, {'measure': 'Plasma Concentration Versus Time Summary of Single Dose of OAP-189', 'timeFrame': 'Pre-dose (2 hours before dosing), 2, 4, 6 hours post-dose on Day 7; Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72 hours post-dose on Day 14', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ = 0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.'}, {'measure': 'Plasma Concentration Versus Time Summary of Multiple Dose of OAP-189', 'timeFrame': 'Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Clinically Significant Physical Examination Abnormalities', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': "Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion."}, {'measure': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) \\>=160 millimeter of mercury (mmHg), (less than equal to) \\<=90 mmHg, \\>=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of \\>=100 mmHg, \\<=50 mmHg, \\>=15 mmHg increase and decrease from baseline; heart rate of \\>=120 beats per minute (bpm), \\<=45 bpm, (greater than) \\>15 bpm increase and decrease from baseline, orthostatic SBP: decrease of \\>=20 mm Hg from sitting value, orthostatic DBP: decrease of \\>=20 mm Hg from sitting value, orthostatic heart rate: increase of \\>=30 bpm from sitting value, oral temperature of (less than) \\<35 or \\>38.3 degree celsius, respiratory rate of \\<10 or \\>25 breaths per minute, weight: maximum increase or decrease of \\>=7 percent (%) from baseline.'}, {'measure': 'Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for clinically significant ECG abnormalities: PR interval \\>=220 millisecond (msec) or a change of \\>=20 msec from baseline values, QRS interval \\>=120 msec, QTc interval \\>450 msec (in males) and \\>470 msec (in females).'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Hematocrit, haemoglobin: decrease of \\>=0.05 L/L and \\>=20 g/L from baseline respectively, WBC count:\\<3\\*10\\^9 /L, neutrophils: \\<1.5\\*10\\^9 /L, platelet count: \\<100\\*10\\^9 /L, eosinophil: \\<0.5\\*10\\^9 /L; prothrombin time, partial thromboplastin time \\>1.5\\*upper limit of normal (ULN); sodium:\\>5 mmol/L above ULN or below lower limit of normal(LLN), potassium \\>0.5 mmol/L above ULN or below LLN, creatinine \\>1.36\\*ULN, blood urea nitrogen \\>1.5\\*ULN, glucose (fasting) \\>0.83 mmol/L above ULN or below LLN, glucose (non-fasting) \\>5 mmol/L above ULN or \\>0.56 below LLN, calcium, magnesium: Change of \\>=0.25 and \\>=0.21 mmol/L from baseline respectively, phosphorus \\>0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of \\>=20g/L, \\>=10 g/L, \\>0.119 mmol/L from baseline respectively, creatinine kinase \\>3\\*ULN, total cholesterol \\>7.77 mmol/L, triglycerides \\>3.39 mmol/L: AST, ALT, total bilirubin \\>2\\*ULN, alkaline phosphatase \\>1.5\\*ULN, alpha-glumatyl transferase, lactate dehydrogenase \\>3\\*ULN.'}, {'measure': 'Number of Participants With Injection Site Reactions', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Injection site reactions included irritation, erythema, pain, hematoma, inflammation.'}, {'measure': 'Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria: Blood glucose levels \\>15 milligram per deciliter (mg/dL) above ULN or \\>15 mg/dL below LLN.'}, {'measure': 'Number of Participants With Hypoglycaemia', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually \\<=50 mg/dL.'}, {'measure': 'Number of Participants With Drug-Induced Liver Injury', 'timeFrame': 'Baseline up to 17 days after last dose of study drug (Day 31)', 'description': 'Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be \\>= 3 times ULN concurrent with a total bilirubin of \\>=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be \\<=2 times ULN.'}, {'measure': 'Change From Baseline in Predose Fasting Glucose Levels at Day 8', 'timeFrame': 'Baseline, Day 8', 'description': 'Fasting glucose levels were determined before administration of OAP-189 using a glucometer.'}, {'measure': 'Change From Baseline in Predose Fasting Glucose Levels at Day 15', 'timeFrame': 'Baseline, Day 15', 'description': 'Fasting glucose levels were determined before administration of OAP-189 using a glucometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3283K1-1008&StudyName=Study%20Evaluating%20Safety%2C%20Tolerability%2C%20And%20Action%20Of%20OAP-189%20In%20Subjects%20With%20Type%202%20Diabetes%20On%20Metformin', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have been diagnosed with type 2 diabetes, with HbA1c level \\>=7.0% and \\<=11.0% and a fasting glucose level \\<=280 mg/dL.\n* Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.\n* Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight \\>=50 kg.\n* Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.\n* Subjects must currently be treated for diabetes with metformin alone at a total daily dose of \\>=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.\n* Nonsmoker.\n\nExclusion Criteria:\n\n* Any significant disease with the exception of diabetes mellitus.\n* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.\n* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.\n* Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.\n* Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.\n* Positive findings of urine drug screen\n* Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.'}, 'identificationModule': {'nctId': 'NCT00970593', 'acronym': '3283K1-1008-US', 'briefTitle': 'Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, PLACEBO CONTROLLED STUDY OF THE EFFECT OF OAP-189 ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF METFORMIN IN DIABETIC SUBJECTS.', 'orgStudyIdInfo': {'id': '3283K1-1008'}, 'secondaryIdInfos': [{'id': 'B2201004', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'OAP-189', 'interventionNames': ['Drug: OAP-189']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo comparator']}], 'interventions': [{'name': 'OAP-189', 'type': 'DRUG', 'description': 'Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation)', 'armGroupLabels': ['OAP-189']}, {'name': 'placebo comparator', 'type': 'DRUG', 'description': 'Group 1 \\& 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clincal Research', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '33169', 'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Cetero Research - Miami', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}