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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Tesaglitazar
* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tesaglitazar|(0.5 or 1 mg)|
|Drug: Pioglitazone|(15, 30 or 45 mg)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Laboratory variables |  |  | 
| Physical examination |  |  | 
| Cardiac evaluation |  |  | 
| Hypoglycemic events |  |  | 
| Electrocardiogram |  |  | 
| Vital signs (blood pressure and pulse) |  |  | 
| Body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.