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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00885118 |
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: BI 10773 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 80 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HbA1c at screening (Visit 1)
Exclusion Criteria:
Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as
Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Japan | |
1245.15.001 Boehringer Ingelheim Investigational Site | Recruiting |
Nakano-ku, Tokyo, Japan | |
1245.15.002 Boehringer Ingelheim Investigational Site | Recruiting |
Koganei, Tokyo, Japan | |
1245.15.003 Boehringer Ingelheim Investigational Site | Recruiting |
Hachioji, Tokyo, Japan | |
1245.15.004 Boehringer Ingelheim Investigational Site | Recruiting |
Yokohama, Kanagawa, Japan | |
1245.15.005 Boehringer Ingelheim Investigational Site | Recruiting |
Suita, Osaka, Japan |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1245.15 |
Study First Received: | April 20, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00885118 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare; 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 |