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Completed

NCT Number: NCT00449553

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pioglitazone and sulphonylurea

Drug

Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.

Other names: ACTOS®, AD4833

Pioglitazone and Metformin

Drug

Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.

Other names: ACTOS®, AD4833

Primary outcomes

  1. Change from baseline in glycosylated hemoglobin.

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).

    Time frame: End of Treatment

  2. Change from baseline in Body Weight.

    Time frame: End of Treatment

  3. 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

  4. Change from baseline in beta-cell function (Homeostasis model assessment).

    Time frame: End of Treatment

  5. Change from baseline in insulin resistance (Homeostasis model assessment).

    Time frame: End of Treatment

  6. Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).

    Time frame: End of Treatment

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 20, 2007
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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