The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue. Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle. This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.
Study Type
OBSERVATIONAL
Enrollment
326
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Unnamed facility
Multiple, Denmark
Unnamed facility
Multiple, Iceland
Unnamed facility
Multiple, Norway
Unnamed facility
Multiple, Sweden
Change from baseline in glycosylated hemoglobin.
Time frame: 6 months
Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).
Time frame: End of Treatment
Change from baseline in Body Weight.
Time frame: End of Treatment
Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%.
Time frame: End of Treatment
Change from baseline in beta-cell function (Homeostasis model assessment).
Time frame: End of Treatment
Change from baseline in insulin resistance (Homeostasis model assessment).
Time frame: End of Treatment
Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).
Time frame: End of Treatment
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Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.