CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5,570 enrolled
Drug / intervention
Metformin +5 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01709305
NCT01709305Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC·interventional·Posted Oct 18, 2012·Updated Aug 21, 2018

In Brief

A Phase 4 clinical trial evaluating Metformin, Sitagliptin, and 4 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 5,570 participants.

Detailed Summary

To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of participants receiving glimepiride added to sitagliptin and metformin combination. The study would be declared successful if at least one of the three primary hypotheses was met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartNov 8, 2012
Primary CompletionApr 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.7 years ago

Interventions

Metformindrug

Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.

Sitagliptindrug

Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food

Acarbosedrug

Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.

Repaglinidedrug

Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.

Glimepiridedrug

Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day

Gliclazidedrug

Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.