GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300105
Recruitment Status : Terminated (The development program has been terminated)
First Posted : March 8, 2006
Last Update Posted : March 17, 2008
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Brief Summary:
This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tesaglitazar Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
Study Start Date : October 2005
Actual Study Completion Date : December 2006

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Primary Outcome Measures :
  1. Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Secondary Outcome Measures :
  1. Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
  2. Time to treatment failure
  3. Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
  4. Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
  5. Markers of insulin resistance by assessment of insulin homeostasis assessment model
  6. Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
  7. Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
  8. Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
  9. Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
  10. Urinary albumin excretion
  11. Central obesity (waist circumference, hip circumference and waist/hip ratio)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 randomized treatment period in GALLANT 4

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
  • Previous enrollment in this long-term extension study
  • 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

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 identifier (NCT number): NCT00300105

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Sponsors and Collaborators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca Identifier: NCT00300105     History of Changes
Other Study ID Numbers: D6160C00047
EudraCT No 2004-005243-97
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: March 2008

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 4

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases