Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Condition: Diabetes Mellitus; Dyslipidemias
MeSH terms: Diabetes Mellitus; Dyslipidemias
Intervention: Pioglitazone and Metformin; Glimepiride and Metformin
Intervention description: Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.; Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Intervention MeSH terms: Metformin; Pioglitazone; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Hyperlipidemias; Drug Therapy

Summary:

      The purpose of this study is to compare pioglitazone and metformin combination therapy, twice
      daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects
      with dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes according to the American Diabetes Association Criteria.

          -  Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as
             monotherapy within the last 12 weeks.

          -  Glycosylated Hemoglobin greater than or equal to 6.5% and less than or equal to 9%.

          -  Dyslipidemia defined as high-density lipoprotein cholesterol less than or equal to
             1.03 mmol/l (40 mg/dL) and/or triglycerides greater than or equal to 1.7 mmol/l (150
             mg/dL).

          -  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.

        Exclusion Criteria:

          -  Type 1 diabetes mellitus.

          -  Insulin-dependent type 2 diabetes mellitus.

          -  Treatment or history of treatment with any insulin formulation other than emergency
             for more than 2 weeks.

          -  Treatment with other oral antidiabetic drugs in addition to metformin within the last
             12 weeks.

          -  Anamnestic history of hypersensitivity to the study drugs or to drugs with similar
             chemical structures.

          -  Is required to take or intends to continue taking any disallowed medication, any
             prescription medication, herbal treatment or over-the counter medication that may
             interfere with evaluation of the study medication, including:

               -  Heparin (and heparin-like drugs)

               -  coumarin

               -  phenprocoumon

               -  hirudin

               -  Protein C

               -  Fondaparinux

               -  antithrombin III

               -  Peroxisome Proliferation Activating Receptor (gamma) agonists

               -  Treatment within the last 12 weeks with:

                    -  fibrates

                    -  gemfibrozil

                    -  niacin

                    -  months

                    -  Rifampicin

               -  Changes in dosage of any statin treatment to lower low-density lipoprotein within
                  2 weeks before study entry and during study participation interval.

               -  Changes in dosage of any anticoagulant treatment with acetyl salicylic acid
                  and/or clopidogrel within 2 weeks before study entry and during study
                  participation interval.

               -  Start of statin and/or anticoagulant treatment during study participation
                  interval.

          -  History of severe or multiple allergies and/ or acute severe infections.

          -  Have had more than one unexplained episode of severe hypoglycemia (defined as
             requiring assistance of another person due to disabling hypoglycemia) within 6 months
             prior to screening visit.

          -  Progressive fatal disease.

          -  Any elective surgery during study participation.

          -  History of drug or alcohol abuse within the last 5 years.

          -  A history of significant cardiovascular (New York Heart Association stage I - IV),
             respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate
             aminotransferase greater than 2.5 times the upper limit of the normal reference
             range), renal (serum creatinine greater than 1.2 mg/dL in women and greater than 1.5
             mg/dL in men, glomerular filtration rate less than 60 ml/min as estimated by the
             Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as
             judged by the investigator, history of macular edema.

          -  Blood donation within the last 30 days.