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Sponsors and Collaborators: |
AstraZeneca Bristol-Myers Squibb |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00614939 |
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Saxagliptin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Short-Term 12-Week, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment With an Additional 40-Week Long-Term Observational Period |
Estimated Enrollment: | 168 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Placebo
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Drug: Placebo
Placebo
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2: Experimental
Saxagliptin
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Drug: Saxagliptin
2.5 mg once daily oral dose
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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:
Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Study Director: | Peter Ohman, MD, PhD | AstraZeneca |
Study Chair: | Deborah Price, MSc | AstraZeneca |
Responsible Party: | AstraZeneca ( Peter Ohman, MD, PhD, Medical Science Director ) |
Study ID Numbers: | D1680C00007, EudraCT number 2007-004951-12 |
Study First Received: | January 31, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00614939 |
Health Authority: | Belarus: Ministry of Health; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health |
DPP-4 inhibitors HbA1c incretins Renal Impairment |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |