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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00558909 |
The primary objective of the current study is to investigate the safety and tolerability of BI 44847 in male and female patients with type 2 diabetes following oral administration of repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 44847 after multiple dosing, including assessment of steady state.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: BI 44847 Drug: placebo for BI 44847 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Selected Oral Doses of BI 44847 as Tablet in Female and Male Patients With Type 2 Diabetes. |
Estimated Enrollment: | 80 |
Estimated Study Completion Date: | November 2007 |
Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Germany | |
Boehringer Ingelheim Investigational Site | |
Neuss, Germany, 41460 | |
Boehringer Ingelheim Investigational Site | |
Berlin, Germany, 14050 | |
Boehringer Ingelheim Investigational Site | |
Mainz, Germany, 55116 | |
Netherlands | |
Boehringer Ingelheim Investigational Site | |
Zuidlaren, Netherlands, 9471 GP |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim BV/Alkmaar |
Study ID Numbers: | 1224.4, EudraCT No.: 2007-000373-35 |
Study First Received: | August 30, 2007 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00558909 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte) |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |