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| ID | Type | Description | Link |
|---|---|---|---|
| SH-SBD-0013 |
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The development program has been terminated
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This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response relationship of tesaglitazar in subjects with type 2 diabetes by the assessment of the effects of each of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) to placebo with respect to fasting plasma glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the following variables from baseline to the end of the randomized treatment period: | ||
| Triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, total cholesterol apolipoproteins (Apo) (Apo A-I, Apo B and Apo CIII), and f |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Japan Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ashino | Japan | ||||
| 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 |
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| Glucose and insulin values during an oral glucose tolerance test |
| Effects on the reduction of insulin and glycosylated hemoglobin A1c levels |
| Effects on the proportion of fasting plasma glucose responders |
| Effects on the proportion of high-density lipoprotein cholesterol responders |
| Effects on the changes from baseline in weight and waist/hip ratio |
| Evaluate the pharmacokinetics of tesaglitazar |
| Assess the safety and tolerability of tesaglitazar compared to placebo |
| Fuchu Keijinkai |
| Japan |
| Research Site | Fujimino | Japan |
| Research Site | Hijirino Koike | Japan |
| Research Site | Houseikai | Japan |
| Research Site | Hyūga | Japan |
| Research Site | Iriuchijima | Japan |
| Research Site | Iwase | Japan |
| Research Site | Katō | Japan |
| Research Site | Kawamata | Japan |
| Research Site | Keishukai Shirakawa | Japan |
| Research Site | Koga | Japan |
| Research Site | Kōhoku | Japan |
| Research Site | Kōsei | Japan |
| Research Site | Kurosawa | Japan |
| Research Site | Nihonmatu | Japan |
| Research Site | Oki | Japan |
| Research Site | Saiseikai Fukuoka | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Takamori | Japan |
| D004700 | Endocrine System Diseases |