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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus
Intervention	Drug: Pioglitazone and sulphonylurea Drug: Pioglitazone and sulphonylurea Drug: Pioglitazone and metformin Drug: Pioglitazone and metformin
Phase	Phase 4
Sponsor	Takeda
Responsible Party	Takeda
ClinicalTrials.gov Identifier	NCT00449553
First Received	March 1, 2007
Last Updated	February 27, 2012
Last verified	February 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 1, 2007
Last Updated Date	February 27, 2012
Start Date	June 2001
Estimated Primary Completion Date	September 2003
Current Primary Outcome Measures	Change from baseline in glycosylated hemoglobin. [Time Frame: 6 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
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
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 Type	Observational
Study Phase	Phase 4
Study Design	Observational Model: Cohort, Time Perspective: Prospective
Condition	Diabetes Mellitus
Intervention	Drug: Pioglitazone and sulphonylurea Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. Other Names: ACTOS® AD4833 Drug: Pioglitazone and sulphonylurea Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. Other Names: ACTOS® AD4833 Drug: Pioglitazone and metformin Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. Other Names: ACTOS® AD4833 Drug: Pioglitazone and metformin Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. Other Names: ACTOS® AD4833
Study Arm (s)	Pioglitazone 15 mg QD + Sulphonylurea Pioglitazone 30 mg QD + Sulphonylurea Pioglitazone 15 mg QD + Metformin Pioglitazone 30 mg QD + Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	326
Estimated Completion Date	September 2003
Estimated Primary Completion Date	September 2003
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Denmark, Iceland, Norway, Sweden

Administrative Information[ + expand ][ + ]

NCT Number	NCT00449553
Other Study ID Numbers	H6E-CP-GLAR
Has Data Monitoring Committee	No
Information Provided By	Takeda
Study Sponsor	Takeda
Collaborators	Eli Lilly and Company
Investigators	Study Director: VP Clinical Science Strategy Takeda Global Research and Developmnet Center Inc
Verification Date	February 2012

Locations[ + expand ][ + ]