Pioglitazone Study of Triglyceride Changes in Subjects With Type 2 Diabetes After Conversion From Rosiglitazone. (COMPLEMENT)

February 27, 2012 updated by: Takeda

A Single-Arm, Open-Label, Multicenter Study Evaluating the Triglyceride Changes in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia Following Treatment Conversion From Rosiglitazone to Pioglitazone HCl in Combination With Stable Statin Therapy

The purpose of this study is to measure the triglyceride changes in subjects with type 2 diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from rosiglitazone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes mellitus is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes has a genetic predisposition, but lifestyle, physical habits and age play important roles in determining its time of onset and severity. Type 2 diabetes is usually the result of a progression from reduced sensitivity of hepatic (liver) and peripheral-tissue cells to circulating insulin (ie, insulin resistance) to a progressive inability of the body to produce adequate insulin to overcome insulin resistance (ie, insulin deficiency due to beta-cell insufficiency) resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 15.7 million people have diabetes, with type 2 diabetes occurring in approximately 90 to 95% of cases.

Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes. Recently introduced drugs for diabetes therapy are the thiazolidinedione class. Thiazolidinediones increase glucose utilization, decrease gluconeogenesis and increase glucose disposal through an incompletely understood mechanism but one associated with binding of the drug to receptors known as peroxisomal proliferator-activated receptors.

Thiazolidinediones are peroxisomal proliferator-activated receptor agonists reducing insulin resistance in muscle cells, adipose (fat) tissue, and hepatic cells (inhibiting hepatic gluconeogenesis) with no direct impact on insulin secretion. Thus peroxisomal proliferator-activated receptor agonists improve glycemic control and result in reduced levels of circulating insulin. Peroxisomal proliferator-activated receptors are found in various tissues important for insulin action, with the greatest concentration of these receptors is in adipose tissue.

Pioglitazone is a peroxisomal proliferator-activated receptor agonist developed by Takeda Chemical Industries, Ltd. (Osaka, Japan).

Participation in this study is anticipated to be approximately 20 weeks.

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico
      • PoncE, Puerto Rico
  • United States
    • Alabama
      • Birmingham,, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Bellflower, California, United States
      • Burlingame, California, United States
      • Fresno,, California, United States
      • La Jolla, California, United States
      • Long Beach, California, United States
      • Pasadena, California, United States
    • Colorado
      • Arvada, Colorado, United States
    • Connecticut
      • Norwalk, Connecticut, United States
      • Waterbury, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • N. Miami Beach, Florida, United States
      • Tallahassee, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Columbus,, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago Heights, Illinois, United States
    • Indiana
      • Evansville,, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Louisiana
      • Lafayette, Louisiana, United States
    • Massachusetts
      • Fall River, Massachusetts, United States
      • Waltham, Massachusetts, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Staten Island, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Centerville, Ohio, United States
      • Dayton, Ohio, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Meadville, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Morristown, Tennessee, United States
      • Murfreesboro, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Houston, Texas, United States
      • Midland, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Ogden, Utah, United States
    • Virginia
      • Orange, Virginia, United States
      • Virginia Beach,, Virginia, United States
    • West Virginia
      • Man, West Virginia, United States
    • Wisconsin
      • Wausau, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
  • Has been taking a stable dose of rosiglitazone for greater than 90 days prior to screening.
  • Has a triglyceride level greater than 200 mg per dL but less than 1000 mg per dL.
  • Has been taking a stable statin therapy for greater than 90 days prior to screening.
  • Has a glycosylated hemoglobin less than 10.5%.

Exclusion Criteria:

  • Type 1 diabetes mellitus.
  • Treated with Gemfibrozil within 90 days of screening.
  • Previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
  • The subject has an alanine aminotransaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Male subjects who have serum creatinine greater than 2.0 mg per dL and female subjects with serum creatinine greater than1.8 mg per dL.
  • Unexplained microscopic hematuria greater than plus 1 confirmed by repeat testing.
  • Male subjects who have hemoglobin less than 10.5 g per dL and female subjects who have hemoglobin less than 10.0 g per dL.
  • Significant cardiovascular disease including, but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV
  • Currently is participating in another investigational study or has participated in an investigational study within the past 30 days.
  • Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.

  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

    • Glucocorticoids (eg. prednisone, cortisone, hydrocortisone, dexamethasone) with the exception of a topical glucocorticoid agent.
    • Gemfibrozil
    • Steroid-joint injections.
    • Thiazolidinediones with the exception of the study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pioglitazone QD
(and stable statin therapy)
Drug: Pioglitazone
Pioglitazone 30 mg to 45 mg, tablets, orally, once daily in combination with stable statin therapy for up to 17 weeks.
Other Names:
  • AD-4833
  • ACTOS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Triglyceride Levels
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Total Cholesterol
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in direct Low Density Lipoprotein cholesterol
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in apolipoprotein B (apoB)
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in apolipoprotein A1 (apoA1)
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in Free Fatty Acids
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in Lipid Fractionation
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit
Change from Baseline in C-reactive Protein
Time Frame: Weeks 8 and 17 or Final Visit
Weeks 8 and 17 or Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-03-TL-OPI-523
  • U1111-1115-8914 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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