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The development program has been terminated
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This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo 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 |
|---|---|---|---|---|
| Galida | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) |
| Measure | Description | Time Frame |
|---|---|---|
| The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide | ||
| Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model | ||
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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 | Altoona | Pennsylvania | United States | |||
| Research Site |
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| Lipid parameters |
| FPG, homeostasis assessment model, insulin, proinsulin, C-peptide |
| Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values |
| 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 |
| Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36) |
| Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only). |
| Ciudad de Buenos Aires |
| Argentina |
| Research Site | Córdoba | Argentina |
| Research Site | Moron- Buenos Aires | Argentina |
| Research Sites | Quilmes - Buenos Aires | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Salta | Argentina |
| Research Site | Curitiba | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Abbotsford British Columbia | British Columbia | Canada |
| Research Site | Chilliwack | British Columbia | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Victoria | British Columbia | Canada |
| Research Site | Dartmouth | Nova Scotia | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Truro | Nova Scotia | Canada |
| Research Site | Windsor | Nova Scotia | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | Niagara Falls | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Scarborough Village | Ontario | Canada |
| Research Site | St. Catharines | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Windsor | Ontario | Canada |
| Research Site | Trois-Rivières | Quebec | Canada |
| Research Site | Chicoutimi | Canada |
| Research Site | Longueuil | Canada |
| Research Site | Montreal | Canada |
| Research Site | St. John's | Canada |
| Research Site | Espoo | Finland |
| Research Site | Helsinki | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Pietarsaar | Finland |
| Research Site | Pori | Finland |
| Research Site | Tampere | Finland |
| Research Site | Guadalajara Jalisco | Mexico |
| Research Site | Mexico City | Mexico |
| Research Site | México | Mexico |
| Research Site | Nuevo León | Mexico |
| Research Site | Puebla City | Mexico |
| Research Site | Torreón | Mexico |
| Research Site | Zapopan | Mexico |
| Research Site | Ås | Norway |
| Research Site | Bergen | Norway |
| Research Site | Elvernum | Norway |
| Research Site | Hamar | Norway |
| Research Site | Horten | Norway |
| Research Site | Kongsberg | Norway |
| Research Site | Lena | Norway |
| Research Site | Loeten | Norway |
| Research Site | Lysaker | Norway |
| Research Site | Oslo | Norway |
| Research Site | Osteraas | Norway |
| Research Site | Skedsmokorset | Norway |
| Research Site | Straume | Norway |
| Research Site | Tronheim | Norway |
| Research Site | Tønsberg | Norway |
| Research Site | Dublin | Ireland | United Kingdom |
| Research Site | Wexford | Ireland | United Kingdom |
| Research Site | Antrim | NI | United Kingdom |
| Research Site | Belfast | United Kingdom |
| Research Site | Cardiff | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Kent | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Mid Glamorgan | United Kingdom |
| Research Site | Pembrokeshire | United Kingdom |
| Research Site | Plymouth | United Kingdom |
| Research SIte | Reading | United Kingdom |
| Research Site | Surrey | United Kingdom |
| Research Site | Wiltshire | United Kingdom |
| 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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