A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate; Comparator: placebo to pioglitazone; Comparator: placebo to Sitagliptin; Comparator: pioglitazone; Glimepiride or gliclazide; Metformin; Pioglitazone rescue therapy
Intervention description: Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks; Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks; Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks; Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks; Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase A (Weeks 0-24): stable dose, as prescribed
by investigator, of metformin; Phase B (Weeks 24-
54): stable dose, as prescribed by investigator, of
metformin; Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glimepiride; Gliclazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 427.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus

Summary:

      This study will evaluate whether the addition of Sitagliptin treatment provides a greater
      decrease in A1C levels compared to placebo in participants with inadequate glycemic control
      on sulfonylurea and metformin combination therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Hemoglobin A1C of ≥7.5% and ≤10.5%

          -  Currently taking a stable dose of metformin (at least 1500 mg/day) and either
             glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered
             dose) for at least 10 weeks prior to study start

          -  Male, or a female who is highly unlikely to conceive

        Exclusion Criteria:

          -  Type 1 diabetes mellitus or ketoacidosis

          -  Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a
             glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required
             insulin therapy within 12 weeks prior to study start

          -  On a weight loss program not in the maintenance phase or on a weight loss medication

          -  History of liver disease, heart failure, heart disease, stroke, high blood pressure,
             blood disorders, or cancer

          -  HIV positive

          -  Pregnant