Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
NCT ID: NCT00449553
Last Updated: 2012-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
326 participants
OBSERVATIONAL
2001-06-30
2003-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pioglitazone 15 mg QD + Sulphonylurea
Pioglitazone and sulphonylurea
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone 30 mg QD + Sulphonylurea
Pioglitazone and sulphonylurea
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone 15 mg QD + Metformin
Pioglitazone and metformin
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Pioglitazone 30 mg QD + Metformin
Pioglitazone and metformin
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to start treatment with pioglitazone.
Exclusion Criteria
* Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Science Strategy
Role: STUDY_DIRECTOR
Takeda Global Research and Developmnet Center Inc
Locations
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Multiple, , Denmark
Multiple, , Iceland
Multiple, , Norway
Multiple, , Sweden
Countries
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Related Links
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Other Identifiers
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U1111-1114-2473
Identifier Type: REGISTRY
Identifier Source: secondary_id
H6E-CP-GLAR
Identifier Type: -
Identifier Source: org_study_id
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