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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00915772 |
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: linagliptin Drug: metformin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid |
Estimated Enrollment: | 784 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | May 2011 (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:
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: | 1218.52, EudraCT2008-008494-59 |
Study First Received: | June 2, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00915772 History of Changes |
Health Authority: | Canada: Health Canada; Croatia: Agency for Medicinal Product and Medical Devices; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; India: Drugs Controller General of India; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Netherlands: Central Committee Research Involving Human Subjects; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Sweden: Regional Ethical Review Board; Tunisia: Ministry of Public Health; Ukraine: State Pharmacological Center - Ministry of Health |
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 |