Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-26 @ 8:13 PM
Study NCT ID:
NCT00667732
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2008-04-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'riddlem@ohsu.edu', 'phone': '503-494-0557', 'title': 'Dr. Matthew Riddle', 'organization': 'Oregon Health and Science University'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.', 'description': 'All participants who received at least one dose of treatment during appropriate period', 'eventGroups': [{'id': 'EG000', 'title': 'Run-In Group', 'description': 'All participants took exenatide twice daily in addition to their Metformin dose.', 'otherNumAtRisk': 38, 'otherNumAffected': 21, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exenatide Randomization Group', 'description': 'After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Randomization Period', 'description': 'After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels', 'otherNumAtRisk': 17, 'otherNumAffected': 10, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Exenatide Open-Label (Previous Exenatide)', 'description': 'Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level', 'otherNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Exenatide Open-Label (Previous Placebo)', 'description': 'Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level', 'otherNumAtRisk': 17, 'otherNumAffected': 12, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomach ache, upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Heartburn, reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'diarrhea, loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hiatal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Sour Taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dental Work', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroenteritis, stomach flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Strep Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Left wrist sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Left 5th toe fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Fall with bruised arm, leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Right Ankle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Right thumb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Left foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Right and left shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Right ankle swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'left toe swelling (gout)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peripheral Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Left wrist pain and numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Elevated Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Lost voice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Injection site redness, itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Left wrist pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Conjunctival hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Dry Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Decreased energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Cold/flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Lymph node enlargement, cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Paronychial infection, finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cold sore, lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Ankle sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Motor vehicle accident with facial laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Rib Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Knee Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hip Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Foot Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthritis, leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Aching elbows', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': "Bell's Palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Numbness, arms, hands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Carpal Tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ulnar neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 10}], 'organSystem': 'Endocrine disorders'}, {'term': 'Fall with leg contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Group', 'description': 'Participants will receive exenatide as part of their diabetes treatment\n\nexenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants will receive placebo rather than exenatide as part of their diabetes treatment\n\nplacebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '9.3'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '9.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of randomized treatment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat. All participants randomized to treatment.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide Group', 'description': 'Participants will receive exenatide as part of their diabetes treatment\n\nexenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of randomized treatment', 'description': 'efficacy criteria, 50% of per protocol participants reached A1c target of \\<6.5%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all participants who completed treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Run-In Group', 'description': 'All participants took exenatide twice daily in addition to their Metformin dose.\n\nA subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time.'}, {'id': 'FG001', 'title': 'Exenatide Group', 'description': 'After run-in participants were randomized to exenatide.\n\nexenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks\n\nmetformin: continued at same dose participant entered study on.\n\nLantus Insulin: titrated per protocol depending on blood sugar levels\n\nIn extension period, participants continued regular regimen with open label exenatide'}, {'id': 'FG002', 'title': 'Placebo Group', 'description': 'After run-in participants were randomized to placebo.\n\nplacebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks\n\nmetformin: continued at same dose participant entered study on.\n\nLantus Insulin: titrated per protocol depending on blood sugar levels\n\nIn extension period, participants continued regular regimen with open label exenatide instead of placebo'}], 'periods': [{'title': 'Run -In (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participants Enrolled in Substudy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Randomization (24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Participants Enrolled in Substudy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Extension (26 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment: March 2007 - February 2009 Participant source: medical clinics, local communities', 'preAssignmentDetails': 'There were 8 weeks of open-label exenatide use before enrollment into the randomized portion of the study to ensure patients ability to tolerate medication before adding insulin to the medication regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide Group', 'description': 'Participants will receive exenatide as part of their diabetes treatment\n\nexenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants will receive placebo rather than exenatide as part of their diabetes treatment\n\nplacebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2008-04-24', 'resultsFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-04', 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment', 'timeFrame': 'After 24 weeks of randomized treatment'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment', 'timeFrame': 'After 24 weeks of randomized treatment', 'description': 'efficacy criteria, 50% of per protocol participants reached A1c target of \\<6.5%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'insulin', 'byetta', 'glucose', 'blood sugar', 'metformin', 'A1c'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.\n\nThe main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.\n\nThere is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients with type 2 diabetes\n* Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for \\> 3 months\n* Age range 30 to 70 years\n* Body mass index 25-45 kg/m2\n* HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)\n* Less than 50% of randomized participants will have used insulin previously\n\nExclusion Criteria:\n\n* Use of more than two antihyperglycemic agents within the last 3 months\n* Use of more than one daily injection of any kind of insulin in the last 3 months\n* Positive anti-GAD antibody (test required in screening)\n* Fasting C-peptide \\<0.5 ng/mL (test required in screening)\n* Pregnancy (test required in screening if able to conceive) or lactation\n* Excessive use of alcohol or evidence of other form of drug dependency\n* Unwillingness or inability to grant informed consent\n* Unwillingness or inability to perform self-monitoring of blood glucose\n* Unwillingness or inability to inject insulin and/or inject exenatide\n* Serum creatinine \\>1.3 mg/dL in women or 1.4 in men\n* Retinopathy which has required photocoagulation for treatment\n* Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol\n* Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control\n* Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying\n* Use prednisone or other systemic glucocorticoid drug in the last 3 months\n* Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months\n* Use of any unproven investigational drug within the last 3 months'}, 'identificationModule': {'nctId': 'NCT00667732', 'acronym': 'MEXELIN', 'briefTitle': 'How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IND 75,235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Participants will receive exenatide as part of their diabetes treatment', 'interventionNames': ['Drug: exenatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Participants will receive placebo rather than exenatide as part of their diabetes treatment', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': '5mcg twice a day, increasing to 10mcg twice a day for 24 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': '5mcg twice a day, increased to 10mcg twice a day for 24 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20003', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Matthew Riddle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amylin Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Matthew Riddle, MD', 'investigatorFullName': 'Matthew C. Riddle', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}