A Study to Assess the Changes in HbA1C and Lipids in 6 Months of Treatment With Pioglitazone, and to Assess Genetic Polymorphisms in PPAR-Gamma - Full Text View

A Study to Assess the Changes in HbA1C and Lipids in 6 Months of Treatment With Pioglitazone, and to Assess Genetic Polymorphisms in PPAR-Gamma

This study has been completed.

Sponsors and Collaborators:	Takeda Global Research & Development Center, Inc. Eli Lilly and Company
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00449553

Purpose

This was a 6-month, prospective, open-label pharmacoepidemiological study in patients with type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Pioglitazone HCl	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Pioglitazone Pioglitazone hydrochloride Lipids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study

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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Estimated Enrollment:	1250
Study Start Date:	June 2001
Study Completion Date:	September 2003

Detailed Description:

This was a phase 4, multi-center, open-label, non-randomized, prospective, longitudinal, pharmacoepidemiological study to evaluate whether the polymorphism in PPAR-gamma (either homozygotic or heterozygotic forms) is associated with a decrease of HbA1C during 6 months of treatment with pioglitazone. Participating patients were receiving, as part of their treatment for type 2 diabetes, either 15 mg or 30 mg pioglitazone in addition to metformin or sulfonylurea. They were evaluated during treatment visits that were part of normal course of care. PPAR-gamma polymorphism was determined at the conclusion of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients greater or equal to 18 years of age
Patients fulfill all requirements for treatment with pioglitazone according to the Summary of Product Characteristics
Patients to start treatment with pioglitazone

Exclusion Criteria:

Patients who have previously participated in this study
Patients who, in the investigator’s opinion, will not comply with the requirements of this protocol and/or it is foreseen they will not conclude the follow-up
Patients who are currently taking or within the last 30 days prior to visit 1 have been treated with combination oral antidiabetic medication(s)
Patients treated with oral antidiabetic medication other than sulfonylurea or metformin (eg, repaglinide, netaglinide or acrarbose) within the last 30 days prior to visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449553

Locations


Denmark

	Multiple, Denmark

Iceland

	Multiple, Iceland

Norway

	Multiple, Norway

Sweden

	Multiple, Sweden

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Eli Lilly and Company

Investigators


Study Director:	Alfonso Perez, MD	Takeda Global Research and Developmnet Center Inc

More Information

Study ID Numbers:	H6E-CP-GLAR
First Received:	March 1, 2007
Last Updated:	March 16, 2007
ClinicalTrials.gov Identifier:	NCT00449553
Health Authority:	Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Iceland: Ministry of Health and Social Security