GALLANT 4 Tesaglitazar vs. Glibenclamide

March 14, 2008 updated by: AstraZeneca

A 52-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

580

Phase

  • Phase 3

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

  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Braine-L'alleud, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Merksem, Belgium
        • Research Site
      • Sint-Gillis-Waas, Belgium
        • Research Site
      • Steenokkerzeel, Belgium
        • Research Site
  • Hong Kong
      • Shatin, N.T., Hong Kong
        • Research Site
  • Hungary
      • Balatonfüred, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Kaposvár, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • Italy
      • Arenzano, Italy
        • Research Site
      • Chiavari (GE), Italy
        • Research Site
      • Chieri, Italy
        • Research Site
      • Gubbio (PG), Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Piacenza, Italy
        • Research Site
      • Reggio Calabria, Italy
        • Research Site
      • Reggio Emilia, Italy
        • Research Site
      • Rho, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Udine, Italy
        • Research Site
  • Malaysia
      • Kuala Lampur, Malaysia
        • Research Site
    • Kota Bharu
      • Kubang Kerian, Kota Bharu, Malaysia
        • Research Site
  • Mexico
      • Veracruz, Mexico
        • Research Site
    • D.f.
      • México, D.f., Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
      • Zapopan, Jalisco, Mexico
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Kongsvinger, Norway
        • Research Site
      • Lysaker, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Skedsmokorset, Norway
        • Research Site
      • Sørumstand, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Ås, Norway
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Pasig City, Philippines
        • Research Site
  • Poland
      • Kraków, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • P³ock, Poland
        • Research Site
      • Toruñ, Poland
        • Research Site
      • Tychy, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • £ód?, Poland
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Ilava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Kysucke Nove Mesto, Slovakia
        • Research Site
      • Lubochna, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Houghton Gauteng, South Africa
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are >=18 years of age
  • Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
  • Diagnosed with type 2 diabetes
  • 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), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
  • History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
  • Creatinine levels above twice the normal range
  • Creatine kinase above 3 times the upper limit of normal
  • Received any investigational product in other clinical studies within 12 weeks
  • 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 glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Outcome Measure
The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Urinary albumin excretion
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Pharmacokinetics of tesaglitazar
Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
Changes in the following variables from baseline to the end of the randomized treatment period:
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, lipoprotein particle size and c

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

September 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 17, 2008

Last Update Submitted That Met QC Criteria

March 14, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6160C00028

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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