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Sponsors and Collaborators: |
AstraZeneca Bristol-Myers Squibb |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00666458 |
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: saxagliptin Drug: sitagliptin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 18-Week, International, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes W |
Estimated Enrollment: | 710 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
saxagliptin add-on to metformin
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Drug: saxagliptin
tablet, per oral, once daily
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2: Active Comparator
sitagliptin add-on to metformin
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Drug: sitagliptin
capsule, per oral, once daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | André Scheen, Professor | Clinical Pharmacology Unit, Liege, Belgium |
Study Director: | Peter Öhman, MD, PhD | AstraZeneca, Wilmington, USA |
Study Chair: | Deborah Price, MSc | AstraZeneca, Wilmington, USA |
Responsible Party: | AstraZeneca Pharmaceuticals ( Peter Öhman, Medical Science Director ) |
Study ID Numbers: | D1680C00002, EudraCT number 2007-006095-11 |
Study First Received: | April 23, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00666458 History of Changes |
Health Authority: | Sweden: The National Board of Health and Welfare; Norway: Norwegian Institute of Public Health; Denmark: National Board of Health; Italy: National Institute of Health; France: Direction Générale de la Santé; South Africa: Department of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Mexico: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines |
Type 2 diabetes metformin |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Metformin Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Pharmacologic Actions Sitagliptin Protease Inhibitors Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |