Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease
Condition: Diabetes Mellitus
MeSH terms: Heart Diseases; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once
      daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and
      mild cardiac disease.
    

Detailed description: 
      Diabetes is a chronic disease involving multiple metabolic defects that include inadequate
      insulin activity and resultant hyperglycemia. Individuals' differing genetic predisposition,
      level of physical activity, and age all contribute to variations in the onset and severity of
      type 2 diabetes. However, progression of this disease typically follows a characteristic
      pattern that begins as a reduced sensitivity of hepatic and peripheral-tissues to circulating
      insulin (ie, insulin resistance). The body's decreasing ability to produce adequate insulin
      to overcome insulin resistance (ie, insulin deficiency due to beta-cell insufficiency)
      results in impaired glucose tolerance and ultimately overt diabetes. In the United States, an
      estimated 17 million people have diabetes, with type 2 diabetes occurring in approximately
      90% to 95% of cases.

      The goal of treating type 2 diabetes is to control blood glucose and thereby prevent
      long-term complications. Adequate glycemic control is paramount in attempting to avert
      chronic complications, including blindness, renal dysfunction and resultant dialysis or renal
      transplantation, neuropathy, and nontraumatic amputations. Intensive glucose management in
      the early stages of diabetes may help forestall complications.

      Pioglitazone is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. Glyburide,
      is an oral antidiabetic agent of the sulfonylurea class. The primary purpose of this study is
      to evaluate the cardiovascular effects of pioglitazone versus glyburide when administered to
      patients with type 2 diabetes mellitus and mild cardiac disease

      Study participation is anticipated to be approximately 1 year and 2 weeks.
    

Intervention name(s): Pioglitazone; Glyburide; Pioglitazone; Glyburide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pioglitazone 15 mg to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 52 weeks.; Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.; Pioglitazone 15 mg or 30 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally once daily for up to 52 weeks.; Glyburide 5 mg or 10 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally once daily for up to 52 weeks.
Other intervention name(s): Actos; AD4833; Actos; AD4833
Intervention MeSH terms: Pioglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy