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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

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Tesaglitazar Drug: Pioglitazone Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : March 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Tesaglitazar
    (0.5 or 1 mg)
    Other Name: Galida
  • Drug: Pioglitazone
    (15, 30 or 45 mg)
    Other Name: Actos


Primary Outcome Measures :
  1. Adverse events
  2. Laboratory variables
  3. Physical examination
  4. Cardiac evaluation
  5. Hypoglycemic events
  6. Electrocardiogram
  7. Vital signs (blood pressure and pulse)
  8. Body weight

Secondary Outcome Measures :
  1. Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
  2. Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
  3. 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
  4. C-reactive protein (CRP)
  5. Central obesity (waist circumference, hip circumference, waist/hip ratio)
  6. Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00226330


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Galida Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00226330     History of Changes
Other Study ID Numbers: D6160C00048
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

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