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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00621140 |
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: BI 1356 Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control |
Enrollment: | 503 |
Study Start Date: | February 2008 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1218.16, Eudract 2007-002448-10 |
Study First Received: | January 14, 2008 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00621140 History of Changes |
Health Authority: | Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb; India: Drug Control General of India; Israel: No regulatory agency approval needed for clinical trials; Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa; Malaysia: Ministry of Health, Malaysia; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw; Romania: National Medicines Agency, Bucharest; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Thailand: Ministry of Public Health; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |