GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

July 27, 2006 updated by: AstraZeneca

Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

Study Overview

Status

Completed

Conditions

Type 2 Diabetes

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

Phase 2

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

Canada
- - Longueuil, Canada
    - Research Site
  - Montreal, Canada
    - Research Site
  - Sherbrooke, Canada
    - Research Site
  - Windsor, Canada
    - Research Site
  - Winnipeg, Canada
    - Research Site
- Alberta
  - Edmonton, Alberta, Canada
    - Research Site
- Ontario
  - Burlington, Ontario, Canada
    - Research Site
  - Courtice, Ontario, Canada
    - Research Site
- Quebec
  - Granby, Quebec, Canada
    - Research Site
  - Laval, Quebec, Canada
    - Research Site
France
- - Andard, France
    - Research Site
  - Angers, France
    - Research Site
  - Avrille, France
    - Research Site
  - Chalonnes-sur-Loire, France
    - Research Site
  - Montrevault, France
    - Research Site
  - Segre, France
    - Research Site
  - Tierce, France
    - Research Site
Mexico
- - Colonia Seccion XVI, Mexico
    - Research Site
  - Colonia Valle, Mexico
    - Research Site
  - Delegacion Cuauhtemoc, Mexico
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States
    - Research Site
  - Huntsville, Alabama, United States
    - Research Site
  - Montgomery, Alabama, United States
    - Research Site
- Arizona
  - Mesa, Arizona, United States
    - Research Site
  - Phoenix, Arizona, United States
    - Research Site
  - Tucson, Arizona, United States
    - Research Site
- California
  - Alhambra, California, United States
    - Research Site
  - Anaheim, California, United States
    - Research Site
  - Dinuba, California, United States
    - Research Site
  - Escondido, California, United States
    - Research Site
  - Fresno, California, United States
    - Research Site
  - Greenbrae, California, United States
    - Research Site
  - Long Beach, California, United States
    - Research Site
  - Mission Viejo, California, United States
    - Research Site
  - Orange, California, United States
    - Research Site
  - Sacramento, California, United States
    - Research Site
  - San Diego, California, United States
    - Research Site
  - Walnut Creek, California, United States
    - Research Site
- Connecticut
  - Stamford, Connecticut, United States
    - Research Site
  - Waterbury, Connecticut, United States
    - Research Site
- District of Columbia
  - Washington, District of Columbia, United States
    - Research Site
- Florida
  - Brandon, Florida, United States
    - Research Site
  - Coral Gables, Florida, United States
    - Research Site
  - DeLand, Florida, United States
    - Research Site
  - Gainesville, Florida, United States
    - Research Site
  - Hollywood, Florida, United States
    - Research Site
  - Miami, Florida, United States
    - Research Site
- Georgia
  - Atlanta, Georgia, United States
    - Research Site
  - Augusta, Georgia, United States
    - Research Site
  - Blue Ridge, Georgia, United States
    - Research Site
  - Dunwoody, Georgia, United States
    - Research Site
- Illinois
  - Gurnee, Illinois, United States
    - Research Site
  - Springfield, Illinois, United States
    - Research Site
- Indiana
  - Evansville, Indiana, United States
    - Research Site
  - Indianapolis, Indiana, United States
    - Research Site
- Kansas
  - Wichita, Kansas, United States
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States
    - Research Site
- Louisiana
  - New Orleans, Louisiana, United States
    - Research Site
- Maine
  - Bangor, Maine, United States
    - Research Site
- Maryland
  - Baltimore, Maryland, United States
    - Research Site
- Massachusetts
  - Salisbury, Massachusetts, United States
    - Research Site
  - Worcester, Massachusetts, United States
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States
    - Research Site
  - Cadillac, Michigan, United States
    - Research Site
- Mississippi
  - Jackson, Mississippi, United States
    - Research Site
- Missouri
  - St. Louis, Missouri, United States
    - Research Site
- Nebraska
  - Omaha, Nebraska, United States
    - Research Site
- Nevada
  - Henderson, Nevada, United States
    - Research Site
  - Las Vegas, Nevada, United States
    - Research Site
  - Pahrump, Nevada, United States
    - Research Site
- New Jersey
  - Lawrenceville, New Jersey, United States
    - Research Site
  - Newark, New Jersey, United States
    - Research Site
- New York
  - Albany, New York, United States
    - Research Site
  - Brooklyn, New York, United States
    - Research Site
  - Buffalo, New York, United States
    - Research Site
  - New Hyde Park, New York, United States
    - Research Site
  - New York, New York, United States
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States
    - Research Site
  - Hickory, North Carolina, United States
    - Research Site
  - Winston-Salem, North Carolina, United States
    - Research Site
- Ohio
  - Canfield, Ohio, United States
    - Research Site
  - Cincinnati, Ohio, United States
    - Research Site
  - Columbus, Ohio, United States
    - Research Site
  - Kettering, Ohio, United States
    - Research Site
  - Lakewood, Ohio, United States
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States
    - Research Site
- Oregon
  - Eugene, Oregon, United States
    - Research Site
- Pennsylvania
  - Altoona, Pennsylvania, United States
    - Research Site
  - Cheswick, Pennsylvania, United States
    - Research Site
  - Penndel, Pennsylvania, United States
    - Research Site
  - Philadelphia, Pennsylvania, United States
    - Research Site
  - Warminster, Pennsylvania, United States
    - Research Site
- Rhode Island
  - Warwick, Rhode Island, United States
    - Research Site
- South Carolina
  - Columbia, South Carolina, United States
    - Research Site
  - Ninety Six, South Carolina, United States
    - Research Site
  - Summerville, South Carolina, United States
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States
    - Research Site
- Texas
  - Arlington, Texas, United States
    - Research Site
  - Corpus Christi, Texas, United States
    - Research Site
  - Dallas, Texas, United States
    - Research Site
  - Lubbock, Texas, United States
    - Research Site
  - North Richland Hills, Texas, United States
    - Research Site
  - San Antonio, Texas, United States
    - Research Site
- Utah
  - Salt Lake City, Utah, United States
    - Research Site
- Virginia
  - Falls Church, Virginia, United States
    - Research Site
  - Norfolk, Virginia, United States
    - Research Site
  - Richmond, Virginia, United States
    - Research Site
- Washington
  - Edmonds, Washington, United States
    - Research Site
  - Renton, Washington, United States
    - Research Site
- West Virginia
  - Huntington, West Virginia, United States
    - Research Site

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

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Provision of a written informed consent
Men or women who are 30 to 80 years of age
Female patients: postmenopausal or surgically sterile
Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

Type 1 diabetes
New York Heart Association heart failure Class III or IV
Treatment with chronic insulin
History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), or to other PPAR g or PPAR a and g agonists.
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Creatinine levels above 1.2 mg/dL
Received any investigational product in other clinical studies within 30 days
Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

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: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)

Secondary Outcome Measures

Outcome Measure
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Pharmacokinetics of tesaglitazar
Changes in the following variables from baseline to the end of the randomized treatment period:
The change in plasma glucose and insulin during an oral glucose tolerance test
Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids
Change in insulin levels and hemoglobin A1c (HbA1c) levels
Responder analyses for FPG, TG, and HDL C according to pre-specified values
To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.

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

April 1, 2002

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

July 31, 2006

Last Update Submitted That Met QC Criteria

July 27, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SH-SBD-0001
GLAD

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.