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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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).
    

Intervention name(s): Metformin; Sitagliptin; Acarbose; Repaglinide; Glimepiride; Gliclazide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food; Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.; Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.; Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day; Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.
Other intervention name(s): Fortamet®; Glucophage®; Glucophage® XR; Glumetza®; Riomet®; Metgluco®; Glycoran®; Januvia®; Tesavel®; Xelevia®; Ristaben®; Precose®; Glucobay™; Prandin®; Fulaidi™; Amaryl®; Glimy; Diamicron MR™
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; Acarbose; Repaglinide; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment