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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2004-000350-24 |
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The development program has been terminated
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This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | |||
| Metformin | Drug | |||
| Dietary and lifestyle modification counseling | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. | ||
| Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp. |
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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 | Helsinki | Finland | ||||
| Research Site |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C501413 | tesaglitazar |
| D008687 | Metformin |
| D004032 | Diet |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009747 |
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| Plasma profile of glucose, insulin and lipids after a mixed meal |
| Calculated insulin secretion |
| Liver oxidation after a mixed meal |
| Energy expenditure and substrate metabolism by indirect calorimetry |
| Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy |
| Waist and hip circumference |
| Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones) |
| Safety and tolerability of tesaglitazar in patients with type 2 diabetes. |
| Pisa |
| Italy |
| Research Site | Oxford | United Kingdom |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |