GALLANT 8 Tesaglitazar Add-on to Metformin

Study Overview
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Brief Summary
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This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

Official Title
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A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Metformin Alone

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Tesaglitazar
* Drug: Metformin


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 Diagnosed with type 2 diabetes Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents 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 Received any investigational product in other clinical studies within 12 weeks 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|
|Drug: Metformin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the following variables from baseline to the end of the randomized treatment period: |  |  | 
| Fasting plasma glucose (FPG), insulin, proinsulin and C-peptide |  |  | 
| Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model |  |  | 
| Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c |  |  | 
| C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio |  |  | 
| FPG, homeostasis assessment model, insulin, proinsulin, C-peptide |  |  | 
| Tumor necrosis factor-alpha, intracellular adhesion molecule-1 |  |  | 
| Fibrinogen |  |  | 
| Urinary albumin excretion |  |  | 
| Waist/hip ratio |  |  | 
| Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values |  |  | 
| Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C |  |  | 
| Pharmacokinetics of tesaglitazar |  |  | 
| Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination |  |  |