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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00328172 |
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: BI 1356 BI Drug: Dose-matched Placebo Drug: Open-label metformin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-Label Metformin Treatment Arm) |
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Glycosylated haemoglobin A1 (HbA1c) of:
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
Exclusion Criteria:
Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1218.5 |
Study First Received: | May 18, 2006 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00328172 History of Changes |
Health Authority: | Australia: Responsilble Ethics Committee; Canada: Health Canada (TPD); Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |