Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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.
Participants coming on study will be stabilized to a standardized metformin dose: this may
take about 10 weeks, and then combination therapy with metformin + sitagliptin will begin
during Phase 1 (Week 0 through Week 20). If a participant has already been on a stabilized
metformin dose, they will start immediately on combination therapy with metformin +
sitagliptin for 20 weeks (Phase 1).
In Phase 2, participants who have failed to achieve adequate glycemic control (A1c ≥ 7% and ≤
10% at Week 16 and fasting finger stick glucose ≥130 mg/dL and ≤280 mg/dL at Week 20) will be
randomized to receive add-on therapy with glimepiride, repaglinide, acarbose, or gliclazide
for 24 weeks (Week 20 through Week 44).
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