Pioglitazone Study of Triglyceride Changes in Subjects With Type 2 Diabetes After Conversion From Rosiglitazone.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the triglyceride changes in subjects with type 2
      diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from
      rosiglitazone.
    

Detailed description: 
      Diabetes mellitus is a chronic disease with multiple metabolic defects that result in
      hyperglycemia arising from inadequate insulin activity. Type 2 diabetes has a genetic
      predisposition, but lifestyle, physical habits and age play important roles in determining
      its time of onset and severity. Type 2 diabetes is usually the result of a progression from
      reduced sensitivity of hepatic (liver) and peripheral-tissue cells to circulating insulin
      (ie, insulin resistance) to a progressive inability of the body to produce adequate insulin
      to overcome insulin resistance (ie, insulin deficiency due to beta-cell insufficiency)
      resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States,
      an estimated 15.7 million people have diabetes, with type 2 diabetes occurring in
      approximately 90 to 95% of cases.

      Therapeutic agents have been developed to address each of the major functional metabolic
      defects associated with type 2 diabetes. Recently introduced drugs for diabetes therapy are
      the thiazolidinedione class. Thiazolidinediones increase glucose utilization, decrease
      gluconeogenesis and increase glucose disposal through an incompletely understood mechanism
      but one associated with binding of the drug to receptors known as peroxisomal
      proliferator-activated receptors.

      Thiazolidinediones are peroxisomal proliferator-activated receptor agonists reducing insulin
      resistance in muscle cells, adipose (fat) tissue, and hepatic cells (inhibiting hepatic
      gluconeogenesis) with no direct impact on insulin secretion. Thus peroxisomal
      proliferator-activated receptor agonists improve glycemic control and result in reduced
      levels of circulating insulin. Peroxisomal proliferator-activated receptors are found in
      various tissues important for insulin action, with the greatest concentration of these
      receptors is in adipose tissue.

      Pioglitazone is a peroxisomal proliferator-activated receptor agonist developed by Takeda
      Chemical Industries, Ltd. (Osaka, Japan).

      Participation in this study is anticipated to be approximately 20 weeks.
    

Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): Pioglitazone 30 mg to 45 mg, tablets, orally, once daily in combination with stable statin therapy for up to 17 weeks.
Other intervention name(s): ACTOS®; AD-4833
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy