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The development program has been terminated
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This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | |||
| Glibenclamide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the following variables from baseline to the end of the randomized treatment period: | ||
| The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide | ||
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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 | Antwerp | Belgium | ||||
| Research Site |
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| 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 |
| Braine-l'Alleud |
| Belgium |
| Research Site | Hasselt | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Merksem | Belgium |
| Research Site | Sint-Gillis-Waas | Belgium |
| Research Site | Steenokkerzeel | Belgium |
| Research Site | Shatin, N.T. | Hong Kong |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Arenzano | Italy |
| Research Site | Chiavari (GE) | Italy |
| Research Site | Chieri | Italy |
| Research Site | Gubbio (PG) | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | Italy |
| Research Site | Padova | Italy |
| Research Site | Perugia | Italy |
| Research Site | Piacenza | Italy |
| Research Site | Reggio Calabria | Italy |
| Research Site | Reggio Emilia | Italy |
| Research Site | Rho | Italy |
| Research Site | Roma | Italy |
| Research Site | Udine | Italy |
| Research Site | Kubang Kerian | Kota Bharu | Malaysia |
| Research Site | Kuala Lampur | Malaysia |
| Research Site | México | D.F. | Mexico |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Veracruz | Mexico |
| Research Site | Ås | Norway |
| Research Site | Bergen | Norway |
| Research Site | Kongsvinger | Norway |
| Research Site | Lysaker | Norway |
| Research Site | Oslo | Norway |
| Research Site | Skedsmokorset | Norway |
| Research Site | Sørumstand | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Manila | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | P³ock | Poland |
| Research Site | Toruñ | Poland |
| Research Site | Tychy | Poland |
| Research Site | Warsaw | Poland |
| Research Site | £ód? | Poland |
| 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 | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Houghton Gauteng | South Africa |
| Research Site | Changhua | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| 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 |
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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