Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Comparator: Placebo; Pioglitazone; Metformin; Glipizide
Intervention description: Sitagliptin 100 mg tablet orally once daily for 26 weeks.; Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks.; Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks.; Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks.; Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431)
      compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic
      control who are taking pioglitazone and metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has type 2 diabetes and is at least 18 years of age and no older than 78 years of age

          -  is male or is a female who is unlikely to conceive children

          -  is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and
             metformin OR metformin and a sulfonylurea agent

        Exclusion Criteria:

          -  has type 1 diabetes

          -  has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1
             (GLP-1) analogue

          -  is on a weight loss program that is not in the maintenance phase or has started a
             weight loss medication within 8 weeks of screening

          -  has had surgery within 30 days of screening or has major surgery planned during the
             study

          -  is on or is likely to require treatment with corticosteroids for more than 2 weeks

          -  has a history of active liver disease, including hepatitis B or C, cirrhosis, or
             gallbladder disease

          -  is human immunodeficiency virus (HIV) positive

          -  has congestive heart failure, or has had new or worsening symptoms of coronary heart
             disease within 3 months prior to screening

          -  has had acute coronary syndrome, coronary artery intervention, or stroke within 3
             months of screening

          -  has severe active peripheral vascular disease

          -  has a history of cancer or blood disorder

          -  is pregnant or breast feeding