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
Intervention: Metformin; Sitagliptin; Acarbose; Repaglinide; Glimepiride; Gliclazide
Intervention description: 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.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; Acarbose; Repaglinide; Gliclazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5570.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has Type 2 Diabetes Mellitus;

          -  Agrees to use an effective method of contraception or must not otherwise be at risk of
             becoming pregnant (female participants).

        Exclusion Criteria:

          -  Has a history of type 1 diabetes mellitus or a history of ketoacidosis;

          -  Has been treated with insulin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a
             Glucagon-like peptide-1 (GLP-1) mimetic or analogue before;

          -  Is on a weight loss program (not in maintenance phase), has started a weight loss
             medication, or has undergone bariatric surgery within 12 months;

          -  Has undergone a surgical procedure within 4 weeks;

          -  Has had new or worsening signs or symptoms of coronary heart disease or congestive
             heart failure within past 3 months, or has acute coronary syndrome, coronary artery
             intervention, or stroke or transient ischemic neurological disorder;

          -  Has a medical history of active liver disease, including chronic active hepatitis B or
             C, primary biliary cirrhosis, or symptomatic gallbladder disease;

          -  Has poorly controlled hypertension;

          -  Has severe peripheral vascular disease;

          -  Has human immunodeficiency virus (HIV);

          -  Has had a clinically important hematological disorder;

          -  Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
             engages in binge drinking;

          -  Has a history of intolerance or hypersensitivity or any contraindication to study
             medications (including sitagliptin, metformin, glimepiride, repaglinide, acarbose or
             gliclazide) based upon the Chinese label;

          -  Is on or likely to require treatment with ≥2 consecutive weeks or repeated courses of
             pharmacologic doses of corticosteroids (other than inhaled, nasal, or topical
             corticosteroids);

          -  Is pregnant or breast feeding or is expecting to conceive or donate eggs during the
             study, including 14 days following the last dose of study drug (female participants).