MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate; Pioglitazone hydrochloride; Matching placebo to sitagliptin; Matching placebo to pioglitazone; Metformin
Intervention description: Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.; Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.; Matching placebo to sitagliptin orally once daily for 54 weeks.; Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.; Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1615.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration
      in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is highly unlikely to conceive

          -  Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA)
             therapies, or is non-naïve based upon the patient's current diet, medical regimen and
             screening A1c patient is currently not on AHA with a screening A1c >=7.5 % and =<11.0
             % patient is currently on either metformin pr sulfonylurea monotherapy with a
             screening A1c >=7.0 % and =<9.0 %

        Exclusion Criteria

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has
             C=peptide value of =<0.8 ng/mL

          -  Patient has previously been treated with insulin, thiazolidinedione (TZD)
             (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (DPP-4) inhibitor
             (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a
             clinical study with any DPP-4 inhibitor or incretin mimetic

          -  Patient is on a weight loss program and is not in the maintenance phase or has started
             a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks

          -  Patient has undergone surgery within the prior 30 days or has major surgery planned
             during the study

          -  Patient has a medical history of active liver disease including chronic active
             hepatitis B or C or symptomatic gallbladder disease including primary biliary
             cirrhosis

          -  Patient has received treatment with an investigational product within 12 weeks prior
             to Visit 1