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

Diabetes Mellitus Clinical Trial

Official title:

A Prospective Study of Associations of Changes in HbA1C and Fasting Blood Lipids Due to Treatment With Pioglitazone for 6 Months and Genetic Polymorphism's in PPAR-gamma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449553
• Other study ID #: H6E-CP-GLAR
• Secondary ID: U1111-1114-2473
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2007
• Last updated: February 27, 2012
• Start date: June 2001
• Est. completion date: September 2003

Study information

• Verified date: February 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencySweden: Medical Products AgencyNorway: Norwegian Medicines AgencyIceland: Ministry of Health and Social Security
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Pioglitazone and sulphonylurea
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
• Pioglitazone and sulphonylurea
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
• Pioglitazone and metformin
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
• Pioglitazone and metformin
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Eli Lilly and Company

Countries where clinical trial is conducted

Denmark,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycosylated hemoglobin.		6 months	No
Secondary	Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).		End of Treatment	No
Secondary	Change from baseline in Body Weight.		End of Treatment	No
Secondary	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	No
Secondary	Change from baseline in beta-cell function (Homeostasis model assessment).		End of Treatment	No
Secondary	Change from baseline in insulin resistance (Homeostasis model assessment).		End of Treatment	No
Secondary	Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).		End of Treatment	No

External Links

•   ACTOS® Package Insert
•   FDA Safety Alerts and Recalls