GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

April 21, 2009 updated by: AstraZeneca

A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin

This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1000

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

  • Brazil
      • Curitiba, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
    • CE
      • Fortaleza, CE, Brazil
        • Research Site
    • GO
      • Goiânia, GO, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Bolton, Ontario, Canada
        • Research Site
      • Brampton, Ontario, Canada
        • Research Site
      • Etobicoke, Ontario, Canada
        • Research Site
      • Hastings, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • Kitchener, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Napanee, Ontario, Canada
        • Research Site
      • Newboro, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Pointe-Claire, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Lahti, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Porvoo, Finland
        • Research Site
      • Savonlinna, Finland
        • Research Site
      • Seinäjoki, Finland
        • Research Site
      • Suonenjoki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vaasa, Finland
        • Research Site
  • France
      • Aix En Provence, France
        • Research Site
      • Ambriere Les Vallees, France
        • Research Site
      • Beziers, France
        • Research Site
      • Briey Cedex, France
        • Research Site
      • Broglie, France
        • Research Site
      • Chateau Gontier, France
        • Research Site
      • Cremeaux, France
        • Research Site
      • Falaise, France
        • Research Site
      • Fontaine Saint Martin, France
        • Research Site
      • Freyming Merlebach, France
        • Research Site
      • GAN, France
        • Research Site
      • Hyeres, France
        • Research Site
      • Jarny, France
        • Research Site
      • Jort, France
        • Research Site
      • L'aigle, France
        • Research Site
      • Lambersart, France
        • Research Site
      • Le Lavandou, France
        • Research Site
      • Lille, France
        • Research Site
      • Lomme Cedex, France
        • Research Site
      • Marange Silvange, France
        • Research Site
      • Marignane, France
        • Research Site
      • Mars La Tour, France
        • Research Site
      • Martigues, France
        • Research Site
      • Mayenne, France
        • Research Site
      • Metz, France
        • Research Site
      • Mondelange, France
        • Research Site
      • Montbrison, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Moutiers, France
        • Research Site
      • Nantes Cedex 01, France
        • Research Site
      • Nantes Cedex 1, France
        • Research Site
      • Paris, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Roanne, France
        • Research Site
      • Roquevaire, France
        • Research Site
      • Rugles, France
        • Research Site
      • Saint Chamond, France
        • Research Site
      • Saint Jean de Luz, France
        • Research Site
      • Tantonville, France
        • Research Site
  • Germany
      • Aschaffenburg, Germany
        • Research Site
      • Beckum, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Düsseldorf, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Gelnhausen, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Künzing, Germany
        • Research Site
      • Nürnberg, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany
        • Research Site
      • Stuttgart, Baden-Württemberg, Germany
        • Research Site
    • Bayern
      • München, Bayern, Germany
        • Research Site
    • Hessen
      • Frankfurt, Hessen, Germany
        • Research Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany
        • Research Site
      • Münster, Nordrhein-Westfalen, Germany
        • Research Site
    • Sachsen
      • Dresden, Sachsen, Germany
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Shatin, Hong Kong
        • Research Site
  • Hungary
      • Balatonfüred, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Gy¿r, Hungary
        • Research Site
      • Kaposvár, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Siófok, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Delhi, India
        • Research Site
      • India, India
        • Research Site
    • Mashatra
      • Mumbai, Mashatra, India
        • Research Site
  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Research Site
    • East Java
      • Malang, East Java, Indonesia
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
      • Petaling Jaya, Malaysia
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Bodø, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Tvedestrand, Norway
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Makati City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
  • Portugal
      • Almada, Portugal
        • Research Site
      • Amadora, Portugal
        • Research Site
      • Caldas da Rainha, Portugal
        • Research Site
      • Elvas, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Portalegre, Portugal
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St.Petersburg, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Switzerland
      • Bern, Switzerland
        • Research Site
      • Chur, Switzerland
        • Research Site
      • Ilanz, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • Monthey, Switzerland
        • Research Site
      • Sion, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
    • Tainan County
      • Yong-Kang City, Tainan County, Taiwan
        • 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

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 the normal range
  • 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
The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary Outcome Measures

Outcome Measure
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 and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Central obesity (waist/hip ratio)

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

March 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 22, 2009

Last Update Submitted That Met QC Criteria

April 21, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6160C00003
  • EudraCT No 2004-02550-56

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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