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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00449553
First received: March 1, 2007
Last updated: February 27, 2012
Last verified: February 2012
  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 Intervention Phase
Diabetes Mellitus
Drug: Pioglitazone and sulphonylurea
Drug: Pioglitazone and metformin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from baseline in glycosylated hemoglobin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 ]

Biospecimen Retention:   Samples With DNA

Whole blood for DNA-analyses


Enrollment: 326
Study Start Date: June 2001
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pioglitazone 15 mg QD + Sulphonylurea Drug: Pioglitazone and sulphonylurea
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
  • ACTOS®
  • AD4833
Pioglitazone 30 mg QD + Sulphonylurea Drug: Pioglitazone and sulphonylurea
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Other Names:
  • ACTOS®
  • AD4833
Pioglitazone 15 mg QD + Metformin Drug: Pioglitazone and metformin
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
  • ACTOS®
  • AD4833
Pioglitazone 30 mg QD + Metformin Drug: Pioglitazone and metformin
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Other Names:
  • ACTOS®
  • AD4833

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving pioglitazone therapy.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eli Lilly and Company
Investigators
Study Director: VP Clinical Science Strategy Takeda Global Research and Developmnet Center Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00449553     History of Changes
Other Study ID Numbers: H6E-CP-GLAR, U1111-1114-2473
Study First Received: March 1, 2007
Last Updated: February 27, 2012
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Iceland: Ministry of Health and Social Security

Keywords provided by Takeda:
Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes
Diabetes Mellitus, Lipoatrophic
Dyslipidemia
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014