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

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 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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Tesaglitazar


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 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

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|nan|

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 |
| --- | --- | --- |
| Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on |  |  | 
| Time to treatment failure |  |  | 
| Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG) |  |  | 
| Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG |  |  | 
| Markers of insulin resistance by assessment of insulin homeostasis assessment model |  |  | 
| Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG |  |  | 
| 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 |  |  | 
| Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C |  |  | 
| Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1 |  |  | 
| Urinary albumin excretion |  |  | 
| Central obesity (waist circumference, hip circumference and waist/hip ratio) |  |  | 

 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 4