GALLEX 1 - Long Term Extension Study 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: NCT00252876
Recruitment Status : Terminated (The development program has been terminated)
First Posted : November 15, 2005
Last Update Posted : March 17, 2008
Information provided by:

November 10, 2005
November 15, 2005
March 17, 2008
March 2005
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Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Same as current
Complete list of historical versions of study NCT00252876 on Archive Site
  • Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
  • Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
  • C-reactive protein
  • Central obesity (waist circumference, hip circumference, waist/hip ratio)
Same as current
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GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.
This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: tesaglitazar
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2007
Not Provided

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 2/22, 5, 7, 8 or 14 studies.

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Estonia,   Finland,   Former Serbia and Montenegro,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Netherlands,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Switzerland,   United Kingdom,   United States,   Vietnam
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Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
March 2008

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