Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
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 Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pioglitazone 15 mg QD + Sulphonylurea
|
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
|
|
Pioglitazone 30 mg QD + Sulphonylurea
|
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
|
|
Pioglitazone 15 mg QD + Metformin
|
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
|
|
Pioglitazone 30 mg QD + Metformin
|
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in glycosylated hemoglobin.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).
Time Frame: End of Treatment
|
End of Treatment
|
|
Change from baseline in Body Weight.
Time Frame: End of Treatment
|
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%.
Time Frame: End of Treatment
|
End of Treatment
|
|
Change from baseline in beta-cell function (Homeostasis model assessment).
Time Frame: End of Treatment
|
End of Treatment
|
|
Change from baseline in insulin resistance (Homeostasis model assessment).
Time Frame: End of Treatment
|
End of Treatment
|
|
Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).
Time Frame: End of Treatment
|
End of Treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: VP Clinical Science Strategy, Takeda Global Research and Developmnet Center Inc
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H6E-CP-GLAR
- U1111-1114-2473 (Registry Identifier: WHO)
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