Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin/Metformin FDC; Comparator: Glimepiride; Matching placebo to Sitagliptin/Metformin FDC; Matching placebo to glimepiride
Intervention description: Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks; Glimepiride tablet orally up to 6 mg daily for 30 Weeks; Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks; Matching placebo to glimepiride tablet orally daily for 30 weeks
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 292.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®),
      MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary
      hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior
      reduction in HbA1c (mean change from baseline) compared to glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

          -  Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and
             has a Visit 1/Screening Visit HbA1c greater than or equal to 7.0% and less than or
             equal to 9.5%; or is currently on AHA monotherapy or low-dose oral combination therapy
             (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a Visit
             1/Screening Visit HbA1c greater than or equal to 6.5% and less than or equal to 9.0%

        Exclusion Criteria:

          -  Has a history of type 1 diabetes mellitus or a history of ketoacidosis

          -  Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue
             (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl
             peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.)
             or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as
             rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1

          -  Required insulin within the prior 12 weeks

          -  Has a hypersensitivity or contraindication to any sulfonylurea medication (such as
             glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin,
             alogliptin, etc.), or biguanide medication (such as metformin, etc.)

          -  Has inadequately controlled hypertension

          -  Has cirrhosis or active liver disease

          -  Has severe cardiac conditions

          -  Is obese

          -  Has human immunodeficiency virus (HIV)