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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Pioglitazone and sulphonylurea; Drug: Pioglitazone and metformin

• Registration Number: NCT00449553
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2001-06
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-20
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

• Fulfills all requirements for treatment with pioglitazone.
• Willing to start treatment with pioglitazone.

Exclusion Criteria

• Has previously participated in this study.
• Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pioglitazone 15 mg QD + Sulphonylurea	Pioglitazone and sulphonylurea	-
Pioglitazone 30 mg QD + Sulphonylurea	Pioglitazone and sulphonylurea	-
Pioglitazone 15 mg QD + Metformin	Pioglitazone and metformin	-
Pioglitazone 30 mg QD + Metformin	Pioglitazone and metformin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycosylated hemoglobin.	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in beta-cell function (Homeostasis model assessment).	End of Treatment
Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).	End of Treatment
Change from baseline in Body Weight.	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%.	End of Treatment
Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).	End of Treatment
Change from baseline in insulin resistance (Homeostasis model assessment).	End of Treatment