Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.

• Change from baseline in glycosylated hemoglobin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  

• Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin). [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  
• Change from baseline in Body Weight. [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: No ]
  
• Change from baseline in beta-cell function (Homeostasis model assessment). [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  
• Change from baseline in insulin resistance (Homeostasis model assessment). [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  
• Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides). [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
  

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.