Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Pioglitazone and metformin; Pioglitazone; Metformin
Intervention description: Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.; Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.; Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Summary:

      The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID),
      combined with metformin versus pioglitazone taken alone and metformin taken alone in treating
      Type 2 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria

          -  Has type 2 diabetes.

          -  Has received no treatment with antidiabetic medication in the 12 weeks prior to
             Screening, other than short-term use defined as less than or equal to 15 days.

          -  A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to
             10.0% at Screening.

          -  Body mass index less than or equal to 45 kg/m2.

          -  Has received counseling on lifestyle modification for type 2 diabetes, including diet
             and exercise.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  Stable condition as determined by a physician.

        Exclusion Criteria

          -  Type 1 diabetes.

          -  Unstable angina or heart failure of any etiology with New York Heart Association
             functional class III or IV.

          -  History of myocardial infarction, cerebrovascular accident, percutaneous coronary
             intervention, coronary artery bypass graft, or transient ischemic attack in the 6
             months prior to Screening.

          -  Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL
             or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.

          -  Has a triglyceride level greater than 500 mg per dL.

          -  Male participant has a hemoglobin level less than 10.5 g per dL or female subject has
             a hemoglobin level less than 10.0 g per dL.

          -  Alanine aminotransferase level of greater than 2.5 times the upper limit of normal,
             active liver disease, or jaundice.

          -  History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse
             (defined as regular or daily consumption of more than 2 alcoholic drinks per day)
             within 2 years prior to Screening.

          -  Has been discontinued from a thiazolidinedione or metformin therapy due to lack of
             efficacy or clinical or laboratory signs of intolerance.

          -  Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma,
             that has not been in remission for at least 5 years prior to the first dose of study
             medication.

          -  History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with
             or without coma.

          -  Any disease or condition at Screening or Randomization that would compromise safety,
             might affect life expectancy, or make it difficult to successfully manage and follow
             the subject according to the protocol.

          -  Currently participating in another investigational study or has participated in an
             investigational study within 30 days prior to randomization.

          -  Is required to take or continues taking any disallowed medication, prescription
             medication, herbal treatment or over-the counter medication that may interfere with
             evaluation of the study medication, including:

               -  Antidiabetic medications other than study medication

               -  Chronically used oral or parenteral glucocorticoids

               -  Niacin greater than 200 mg per day, including niacin-containing products such as
                  Advicor

               -  Chronically used steroid-joint injections