Clinical trial NCT00449553: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes
Diabetes Mellitus, Lipoatrophic
Dyslipidemia
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-03-20
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving pioglitazone therapy.

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.

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.

Primary outcomes:
measure: Change from baseline in glycosylated hemoglobin.
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).
timeFrame: End of Treatment
measure: Change from baseline in Body Weight.
timeFrame: End of Treatment
measure: 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%.
timeFrame: End of Treatment
measure: Change from baseline in beta-cell function (Homeostasis model assessment).
timeFrame: End of Treatment
measure: Change from baseline in insulin resistance (Homeostasis model assessment).
timeFrame: End of Treatment
measure: Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).
timeFrame: End of Treatment
Other outcomes:
Locations:
city: Multiple
country: Denmark
city: Multiple
country: Iceland
city: Multiple
country: Norway
city: Multiple
country: Sweden
Study officials:
affiliation: Takeda Global Research and Developmnet Center Inc
name: VP Clinical Science Strategy
role: STUDY_DIRECTOR
References: