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GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

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ClinicalTrials.gov Identifier: NCT00261352
Recruitment Status : Terminated (The development program has been terminated)
First Posted : December 5, 2005
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tesaglitazar Drug: Metformin Drug: Fenofibrate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Actual Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary Outcome Measures :
  1. Changes in the following variables from baseline to the end of the randomized treatment period:
  2. 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)
  3. Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
  4. The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
  5. 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)
  6. Central obesity (waist/hip ratio)
  7. Pharmacokinetics of tesaglitazar
  8. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261352


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Galida Medical Science DIrector, MD AstraZeneca
More Information
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ClinicalTrials.gov Identifier: NCT00261352    
Other Study ID Numbers: D6160C00003
EudraCT No 2004-02550-56
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Fenofibrate
 Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents