MK0431A Comparative Study in Patients With Type 2 Diabetes

• Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

• Drug: sitagliptin phosphate (+) metformin hydrochloride
  sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
  Other Names:

  • MK0431A
  • Janumet™
• Drug: metformin
  metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
  Other Name: metformin

• Experimental: 1
  Arm 1: drug
  Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
• Active Comparator: 2
  Arm 2: active comparator
  Intervention: Drug: metformin

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
• Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
• Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
• Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria:

• Patient has type 1 diabetes mellitus or history of ketoacidosis