GALLANT 22 Tesaglitazar vs. Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252837
Recruitment Status : Terminated (The development program has been terminated)
First Posted : November 15, 2005
Last Update Posted : March 17, 2008
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tesaglitazar Behavioral: Dietary and Lifestyle counseling Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2005
Actual Study Completion Date : December 2006

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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. 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
  3. C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
  4. Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
  5. Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  6. Fibrinogen
  7. Proportion of patients with microalbuminuria
  8. Waist/hip ratio
  9. Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
  10. Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
  11. Pharmacokinetics of tesaglitazar
  12. 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
  13. Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
  14. Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.

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

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

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 identifier (NCT number): NCT00252837

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Sponsors and Collaborators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca Identifier: NCT00252837     History of Changes
Other Study ID Numbers: D6160C00055
EudraCT No 2004-004374-90
First Posted: November 15, 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