GALLANT 22 Tesaglitazar vs. Placebo

March 14, 2008 updated by: AstraZeneca

A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 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 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

475

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

  • Australia
      • Adelaide, Australia
        • Research Site
      • Cairns, Australia
        • Research Site
      • Gosford, Australia
        • Research Site
      • Keswick, Australia
        • Research Site
      • Kippa Ring, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
      • Miranda, Australia
        • Research Site
      • Nowra, Australia
        • Research Site
      • Wollongong, Australia
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hodonin, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
      • Pribram, Czech Republic
        • Research Site
      • Semily, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
      • Usti nad Labem, Czech Republic
        • Research Site
  • Estonia
      • Paide, Estonia
        • Research Site
      • Pärnu, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
      • Viljandi, Estonia
        • Research Site
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Briollay, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Saint Benoit, France
        • Research Site
      • Saint Ouen, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Trelaze, France
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
  • Hungary
      • Balatonfüred, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Kaposvár, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Jekabpils, Latvia
        • Research Site
      • Madona, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
      • SIgulda, Latvia
        • Research Site
      • Talsi, Latvia
        • Research Site
      • Valmiera, Latvia
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Klaipeda, Lithuania
        • Research Site
      • Panevezys, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Norway
      • Aurskog, Norway
        • Research Site
      • Bergen, Norway
        • Research Site
      • Enebakk, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Haugesund, Norway
        • Research Site
      • Hønefoss, Norway
        • Research Site
      • Inderøy, Norway
        • Research Site
      • Larvik, Norway
        • Research Site
      • Lierskogen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Rolvsøy, Norway
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Pasig City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Poznań, Poland
        • Research Site
      • Radom, Poland
        • Research Site
      • Rzeszow, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Toruñ, Poland
        • Research Site
      • Tychy, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
      • Zielona Gora, Poland
        • Research Site
    • Ochojec
      • Katowice, Ochojec, Poland
        • Research Site
  • Slovakia
      • Dolny Kubin, Slovakia
        • Research Site
      • Levice, Slovakia
        • Research Site
      • Lubochna, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Nove Zamky, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Sahy, Slovakia
        • Research Site
      • Trencin, Slovakia
        • Research Site
      • Velky Meder, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • Sweden
      • Borås, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Mölndal, Sweden
        • Research Site
      • Partille, Sweden
        • Research Site
      • Skene, Sweden
        • Research Site
      • Stenungsund, Sweden
        • Research Site
      • Uddevalla, Sweden
        • Research Site
      • Vänersborg, Sweden
        • Research Site
      • Åmål, Sweden
        • 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

18 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
  • Drug-naïve (ie, no use of antidiabetic drug[s], for at least 24 weeks prior to visit 1).

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
  • 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
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Waist/hip ratio
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Pharmacokinetics of tesaglitazar
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
Proportion of patients with microalbuminuria
Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
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
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.

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

April 1, 2005

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (ESTIMATE)

November 15, 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

  • D6160C00055
  • EudraCT No 2004-004374-90

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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