Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01614769
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C057619', 'term': 'glimepiride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo in a treatment period.', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glimepiride 2 mg', 'description': 'Participants received 2 mg Glimepiride in a treatment period.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Glimepiride 4 mg', 'description': 'Participants received 4 mg Glimepiride in a treatment period.', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recovery Time From Hypoglycemia to Euglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo in a treatment period.'}, {'id': 'OG001', 'title': 'Glimepiride 2 mg', 'description': 'Participants received 2 mg Glimepiride in a treatment period.'}, {'id': 'OG002', 'title': 'Glimepiride 4 mg', 'description': 'Participants received 4 mg Glimepiride in a treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.49', 'groupId': 'OG000', 'lowerLimit': '48.20', 'upperLimit': '100.77'}, {'value': '88.90', 'groupId': 'OG001', 'lowerLimit': '57.65', 'upperLimit': '120.14'}, {'value': '109.81', 'groupId': 'OG002', 'lowerLimit': '81.05', 'upperLimit': '138.57'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '14.41', 'ciLowerLimit': '-22.98', 'ciUpperLimit': '51.80', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '35.33', 'ciLowerLimit': '-2.08', 'ciUpperLimit': '72.74', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements \\>= 70 mg/dL, is called the recovery time.', 'unitOfMeasure': 'Minutes', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.'}, {'type': 'PRIMARY', 'title': 'Rate of Recovery From Hypoglycemia to Euglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo in a treatment period.'}, {'id': 'OG001', 'title': 'Glimepiride 2 mg', 'description': 'Participants received 2 mg Glimepiride in a treatment period.'}, {'id': 'OG002', 'title': 'Glimepiride 4 mg', 'description': 'Participants received 4 mg Glimepiride in a treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.40'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.31'}, {'value': '0.19', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '0.27'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.10', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.00', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.13', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '-0.03', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.', 'unitOfMeasure': 'mg/dL/minute', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.'}, {'type': 'PRIMARY', 'title': 'Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo in a treatment period.'}, {'id': 'OG001', 'title': 'Glimepiride 2 mg', 'description': 'Participants received 2 mg Glimepiride in a treatment period.'}, {'id': 'OG002', 'title': 'Glimepiride 4 mg', 'description': 'Participants received 4 mg Glimepiride in a treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.61', 'groupId': 'OG000', 'lowerLimit': '17.55', 'upperLimit': '27.68'}, {'value': '17.58', 'groupId': 'OG001', 'lowerLimit': '11.78', 'upperLimit': '23.38'}, {'value': '15.34', 'groupId': 'OG002', 'lowerLimit': '9.94', 'upperLimit': '20.75'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.03', 'ciLowerLimit': '-11.12', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.27', 'ciLowerLimit': '-13.30', 'ciUpperLimit': '-1.24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'description': 'Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.'}, {'id': 'FG001', 'title': 'Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'description': 'Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.'}, {'id': 'FG002', 'title': 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'description': 'Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.'}, {'id': 'FG003', 'title': 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg', 'description': 'Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.'}, {'id': 'FG004', 'title': 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'description': 'Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.'}, {'id': 'FG005', 'title': 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'description': 'Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Discontinued due to Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '7-Day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '7-Day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All randomized participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2012-06-06', 'resultsFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-02', 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery Time From Hypoglycemia to Euglycemia', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements \\>= 70 mg/dL, is called the recovery time.'}, {'measure': 'Rate of Recovery From Hypoglycemia to Euglycemia', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.'}, {'measure': 'Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery', 'timeFrame': 'From 1 to 180 minutes post hypoglycemic clamp', 'description': 'The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0000-253&kw=0000-253&tab=access', 'type': 'CSR Snyposis Link'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for \\>= 12 weeks prior to screening visit.\n* Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.\n* Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.\n* Is in good health, other than T2DM.\n* Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.\n* Will follow American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit.\n* At screening visit has a Body Mass Index (BMI) =\\< 40 kg/m\\^2.\n* At screening visit has a Hemoglobin A1c (HbA1c) of \\>= 7% and \\< 10% (+/- 0.1%).\n* On the morning of randomization at predose has fasting plasma glucose (FPG) \\>= 126 mg/dL, and =\\< 250 mg/dL.\n\nExclusion Criteria:\n\n* Has a history of stroke, chronic seizures, or major neurological disorder.\n* Has a history of any illness that might confound the results of the study or pose additional risk to the participant.\n* Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =\\< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.\n* Has a history of neoplastic disease.\n* Is a nursing mother.\n* Has been treated =\\< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, or insulin.\n* Has received treatment within =\\< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (PPARγ) agonist.\n* Is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study.\n* Consumes excessive amounts of alcohol or caffeinated beverages.\n* Is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months.\n* Has had major surgery, lost 500 mL of blood, or participated in another investigational study within 4 weeks prior to screening visit.\n* Is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit.\n* Has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives."}, 'identificationModule': {'nctId': 'NCT01614769', 'briefTitle': 'Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0000-253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'description': 'Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'description': 'Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'description': 'Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg', 'description': 'Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'description': 'Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'description': 'Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Glimepiride 2 mg', 'Drug: Glimepiride 4 mg', 'Procedure: Hypoglycemic Clamp']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.', 'armGroupLabels': ['Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg']}, {'name': 'Glimepiride 2 mg', 'type': 'DRUG', 'description': 'One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.', 'armGroupLabels': ['Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg']}, {'name': 'Glimepiride 4 mg', 'type': 'DRUG', 'description': 'Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.', 'armGroupLabels': ['Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg']}, {'name': 'Hypoglycemic Clamp', 'type': 'PROCEDURE', 'description': 'On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.', 'armGroupLabels': ['Glimepiride 2 mg → Glimepiride 4 mg → Placebo', 'Glimepiride 2 mg → Placebo → Glimepiride 4 mg', 'Glimepiride 4 mg → Glimepiride 2 mg → Placebo', 'Glimepiride 4 mg → Placebo → Glimepiride 2 mg', 'Placebo → Glimepiride 2 mg → Glimepiride 4 mg', 'Placebo → Glimepiride 4 mg → Glimepiride 2 mg']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}