GALLANT 2 Tesaglitazar vs. Placebo

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252772
First received: November 10, 2005
Last updated: April 21, 2009
Last verified: April 2009

November 10, 2005
April 21, 2009
September 2004
Not Provided
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Same as current
Complete list of historical versions of study NCT00252772 on ClinicalTrials.gov Archive Site
  • 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
  • C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
  • Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
  • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  • Fibrinogen
  • Proportion of patients with microalbuminuria
  • Waist/hip ratio
  • Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
  • Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
  • 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
  • Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
  • 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
  • • C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
  • • Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
  • • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  • • Fibrinogen
  • • Proportion of patients with microalbuminuria
  • • Waist/hip ratio
  • • Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
  • • Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
  • • 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
  • • Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Not Provided
Not Provided
 
GALLANT 2 Tesaglitazar vs. Placebo
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Tesaglitazar
  • Behavioral: Dietary and Lifestyle counseling
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
November 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00252772
D6160C00026
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP