Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: Sitagliptin; Comparator: Placebo; Comparator: Pioglitazone; Metformin
Intervention description: Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24; Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24; Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8; Metformin rescue for patients meeting
pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8
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: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and efficacy of an investigational drug
      in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus (T2DM)

          -  Patient is 18 years of age (or older)

          -  Patient is not pregnant or breast-feeding and does not plan to become pregnant for the
             duration of the study and poststudy follow-up period

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis

          -  Patient required insulin within the prior 8 weeks

          -  Patient is on a weight loss program and is not in the maintenance phase

          -  Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the
             prior 8 weeks

          -  Patient is on or likely to require treatment with treatment with immunosuppressive
             agents (e.g., cyclosporin, methotrexate)

          -  Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic
             gallbladder disease

          -  Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder
             (e.g., multiple sclerosis or polymyositis)

          -  Patient has any of the following disorders within the past 6 months:

        Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke
        or transient ischemic neurological disorder.

          -  Patient has new or worsening signs or symptoms of coronary heart disease within the
             past 3 months

          -  Patient has severe peripheral vascular disease

          -  Patient has congestive heart failure

          -  Patient is HIV positive

          -  Patient has a clinically important hematological disorder (e.g., aplastic anemia,
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

          -  Patient has a history of neoplastic disease

          -  Patient has a history of alcohol or drug abuse within the past 3 years

          -  Patient has viral hepatitis (hepatitis B or C)