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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00601250 |
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: BI 1356 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy |
Estimated Enrollment: | 600 |
Study Start Date: | January 2008 |
Estimated 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:
Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
Exclusion Criteria:
Pre-menopausal women who:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1218.17, EudraCT No.: 2007-002457-24 |
Study First Received: | January 15, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00601250 |
Health Authority: | Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Finland: National Agency for Medicines; Greece: National Organization of Medicines (EOF) National Ethics Committee; India: Ministry of Health and Family Welfare; Israel: Ministry of Health; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); New Zealand: Multicentre Ethics Committee/Medsafe; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Sweden: Sweden; Läkemedelsverket (Medical Product Agency); United States: Food and Drug Administration |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |