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GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00226330
Recruitment Status : Terminated (The development program has been terminated)
First Posted : September 27, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

September 23, 2005
September 27, 2005
November 19, 2010
March 2005
December 2006   (Final data collection date for primary outcome measure)
  • Adverse events
  • Laboratory variables
  • Physical examination
  • Cardiac evaluation
  • Hypoglycemic events
  • Electrocardiogram
  • Vital signs (blood pressure and pulse)
  • Body weight
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Complete list of historical versions of study NCT00226330 on ClinicalTrials.gov Archive Site
  • Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
  • Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
  • Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
  • C-reactive protein (CRP)
  • Central obesity (waist circumference, hip circumference, waist/hip ratio)
  • Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
  • Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
  • Lipid variables (triglyderide, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
  • Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
  • CRP
  • Central obesity (waist circumference, hip circumference, waist/hip ratio)
  • Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Not Provided
Not Provided
 
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Tesaglitazar
    (0.5 or 1 mg)
    Other Name: Galida
  • Drug: Pioglitazone
    (15, 30 or 45 mg)
    Other Name: Actos
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
1100
Same as current
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
  • Completed the last two visits of the randomized treatment period in GALLANT 6

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, or neutropenia (low white blood cells)
  • Creatinine levels of above twice the normal range
  • Creatine kinase of above 3 times the upper limit of normal
  • Previous enrollment in this long-term extension study
  • Any clinically significant abnormality identified by 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Finland,   Mexico,   United Kingdom,   United States
 
 
NCT00226330
D6160C00048
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: 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