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Clinical Trial Details

Trial ID: L6908
Source ID: NCT01709305
Associated Drug: Metformin
Title: A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01709305/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin|DRUG: Sitagliptin|DRUG: Acarbose|DRUG: Repaglinide|DRUG: Glimepiride|DRUG: Gliclazide
Outcome Measures: Primary: Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2), HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction., Phase 2 Baseline (Week 20) and Week 44 | Secondary: Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2), Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used., Phase 2 Baseline (Week 20), Week 44|Percentage of Participants With Hypoglycemia Events (Phase 2), Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported., From Week 20 through Week 44|Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2), The percentage of participants with a GI AE of "nausea" was reported., From Week 20 through Week 44|Percentage of Participants With a GI AE of Vomiting (Phase 2), The percentage of participants with a GI AE of "vomiting" was reported., From Week 20 through Week 44|Percentage of Participants With a GI AE of Diarrhea (Phase 2), The percentage of participants with a GI AE of "diarrhea" was reported., From Week 20 through Week 44|Percentage of Participants With a GI AE of Abdominal Pain (Phase 2), The percentage of participants with a GI AE of "abdominal pain" was reported., From Week 20 through Week 44
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 5570
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-11-08
Completion Date: 2015-04-17
Results First Posted: 2016-05-11
Last Update Posted: 2018-08-21
Locations:
URL: https://clinicaltrials.gov/show/NCT01709305