GALLANT 6 Tesaglitazar vs. Pioglitazone

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00214565
First received: September 20, 2005
Last updated: November 17, 2010
Last verified: November 2010

September 20, 2005
November 17, 2010
August 2004
October 2006   (final data collection date for primary outcome measure)
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 NCT00214565 on ClinicalTrials.gov Archive Site
  • The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
  • Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
  • Lipid parameters
  • FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
  • Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
  • 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
  • Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
  • Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
  • - The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
  • - Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
  • - Lipid parameters
  • - FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
  • - Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
  • - 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
  • - Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
  • - Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
Not Provided
Not Provided
 
GALLANT 6 Tesaglitazar vs. Pioglitazone
A 24-Wk Randomised, Double-Blind, Multi-Centre, Active-Controlled (Pioglitazone) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg 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 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Galida
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
1450
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are ³18 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Finland,   Mexico,   Norway,   United Kingdom
 
NCT00214565
D6160C00030
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
AstraZeneca
November 2010

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