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

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00226330
First received: September 23, 2005
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Tesaglitazar
Drug: Pioglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events
  • Laboratory variables
  • Physical examination
  • Cardiac evaluation
  • Hypoglycemic events
  • Electrocardiogram
  • Vital signs (blood pressure and pulse)
  • Body weight

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 1100
Study Start Date: March 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tesaglitazar
    (0.5 or 1 mg)
    Other Name: Galida
    Drug: Pioglitazone
    (15, 30 or 45 mg)
    Other Name: Actos
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226330

  Show 171 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Galida Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226330     History of Changes
Other Study ID Numbers: D6160C00048
Study First Received: September 23, 2005
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.

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

ClinicalTrials.gov processed this record on June 17, 2013