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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00749190 |
The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: BI 10773 Drug: placebo Drug: sitagliptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised, Double-Blind, Placebo-Controlled Group Comparison Study Evaluating Safety and Efficacy of Different Dosages of BI 10773 in Comparison to Placebo Given for 12 Weeks as Add on Therapy to Ongoing Metformin or Sulfonylurea in Patients With Type 2 Diabetes Mellitus (Includes Sitagliptin Open-Label Arm) |
Estimated Enrollment: | 448 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1245.10, EudraCT 2008-000641-54 |
Study First Received: | September 8, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00749190 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia (A.N.M.A.T); Austria: Federal Office for Safety in Health Care; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Estonia: State Agency of Medicines, EE-5041Tartu; Finland: National Agency for Medicines; France: French Health Products Safety Agency 143-147 boulevard Anatole France 93285; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest; Latvia: State Agency of Medicines, LV-1003 Riga; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Spanish Agency of Medicines; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Glucose Metabolism Disorders Pharmacologic Actions Protease Inhibitors Sitagliptin |