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GALLANT 4 Tesaglitazar vs. Glibenclamide

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ClinicalTrials.gov Identifier: NCT00255541
Recruitment Status : Terminated (The development program has been terminated)
First Posted : November 21, 2005
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide




Primary Outcome Measures :
  1. Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures :
  1. Changes in the following variables from baseline to the end of the randomized treatment period:
  2. The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
  3. Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
  4. 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
  5. C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
  6. FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
  7. Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  8. Fibrinogen
  9. Urinary albumin excretion
  10. Waist/hip ratio
  11. Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
  12. Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
  13. Pharmacokinetics of tesaglitazar
  14. 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


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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 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

Information from the National Library of Medicine

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): NCT00255541


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00255541     History of Changes
Other Study ID Numbers: D6160C00028
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs