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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2004-001144-71 |
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The development program has been terminated
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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 sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar 0.5 or 1 mg | Drug | |||
| Glibenclamide 2.5, 5, 10 or 15 mg | 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 | Adelaide | Australia | ||||
| 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 |
| Brisbane |
| Australia |
| Research Site | Cairns | Australia |
| Research Site | Geelong | Australia |
| Research Site | Melbourne | Australia |
| Research Site | Perth | Australia |
| Research Site | Sydney | Australia |
| Research Site | Tasmania | Australia |
| Research Site | Angers | France |
| Research Site | Hyères | France |
| Research Site | La Garde | France |
| Research Site | La Seyne-sur-Mer | France |
| Research Site | Laval | France |
| Research Site | Le Brusc | France |
| Research Site | Le Lavandou | France |
| Research Site | Montrevault | France |
| Research Site | Paris | France |
| Research Site | Saint-Cyr | France |
| Research Site | Six-Fours-les-Plages | France |
| Research Site | Tiercé | France |
| Research Site | Toulon | France |
| Research Site | Ashkelon | Israel |
| Research Site | Haifa | Israel |
| Research Site | Holon | Israel |
| Research Site | Jerusalem | Israel |
| Research Site | Rishon LeZiyyon | Israel |
| Research Site | Safed | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Tel Litwinsky | Israel |
| Research Site | Bergen | Norway |
| Research Site | Elverum | Norway |
| Research Site | Enebakk | Norway |
| Research Site | Fredrikstad | Norway |
| Research Site | Gamle Fredrikstad | Norway |
| Research Site | Hamar | Norway |
| Research Site | Haugesund | Norway |
| Research Site | Hurdal | Norway |
| Research Site | Inderøy | Norway |
| Research Site | Lena | Norway |
| Research Site | Levanger | Norway |
| Research Site | Oslo | Norway |
| Research Site | Rud | Norway |
| Research Site | Sedsmokorset | Norway |
| Research Site | Soerumsand | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Manila | Philippines |
| Research Site | Marikina City | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Cape Town | South Africa |
| Research Site | Chatsworth | South Africa |
| Research Site | Gauteng | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Seoul | South Korea |
| Research Site | Suwon | South Korea |
| Research Site | Alzira (Valencia) | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Guissona (Lleida) | Spain |
| Research Site | Madrid | Spain |
| Research Site | San Sebastian de Los Reyes ( Madrid) | Spain |
| Research Site | San Vicente de Raspeig (Alicante) | Spain |
| Research Site | Valencia | Spain |
| Research Site | Dublin | Ireland | United Kingdom |
| Research Site | Aberdeen | United Kingdom |
| Research Site | Barnsley | United Kingdom |
| Research Site | Bath | United Kingdom |
| Research Site | Belfast | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Cardiff | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | East Sussex | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Liverpool | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Shrewsbury | United Kingdom |
| Research Site | Surrey | United Kingdom |
| Research Site | West Midlands | United Kingdom |
| Research Site | Wiltshire | United Kingdom |
| Research Site | Wrexham | United Kingdom |
| Research Site | Hanoi | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| 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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