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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2004-005243-97 |
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The development program has been terminated
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Galida Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hasselt | Belgium | ||||
| Research Site |
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| 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) |
| Liège |
| Belgium |
| Research Site | Sint-Gillis-Waas | Belgium |
| Research Site | Steenokkerzeel | Belgium |
| Research Site | Shatin | Hong Kong |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Gubbio | Italy |
| Research Site | Milan | Italy |
| Research Site | Perugia | Italy |
| Research Site | Piacenza | Italy |
| Research Site | Reggio Emilia | Italy |
| Research Site | Udine | Italy |
| Research Site | Kubang Kerian | Kelantan | Malaysia |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Makati City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | Płock | Poland |
| Research Site | Torun | Poland |
| Research Site | Tychy | Poland |
| Research Site | Warsaw | Poland |
| Research Site | £ód? | Poland |
| Research Site | Banská Bystrica | Slovakia |
| Research Site | Bratislava | Slovakia |
| Research Site | Ilava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Kysucké Nové Mesto | Slovakia |
| Research Site | Lučenec | Slovakia |
| Research Site | Ľubochňa | Slovakia |
| Research Site | Nitra | Slovakia |
| Research Site | Prešov | Slovakia |
| Research Site | Trnava | Slovakia |
| Research Site | Johannesburg | Gauteng | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Bangkok | Thailand |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C501413 | tesaglitazar |
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