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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00251940 |
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
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: Tesaglitazar 0.5 or 1 mg Drug: Glibenclamide 2.5, 5, 10 or 15 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone |
Estimated Enrollment: | 555 |
Study Start Date: | July 2004 |
Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Galida Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D6160C00032, EudraCT No 2004-001144-71 |
Study First Received: | November 9, 2005 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00251940 History of Changes |
Health Authority: | United Kingdom: Department of Health |
Glyburide Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Glyburide Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |