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| Sponsor: | AstraZeneca |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00660907 |
Purpose
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: dapagliflozin Drug: glipizide Drug: metformin hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Adult Patients With Type 2 Diabetes |
| Estimated Enrollment: | 746 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
dapagliflozin plus metformin
|
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 104 weeks
Drug: metformin hydrochloride
tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 114 weeks
|
|
2: Active Comparator
glipizide plus metformin
|
Drug: glipizide
capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 104 weeks
Drug: metformin hydrochloride
tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 114 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 84 Study Locations| Principal Investigator: | Michael A. Nauck, Prof. Dr. med. | Diabeteszentrum Bad Lauterberg, Germany |
More Information
| Responsible Party: | AstraZeneca ( Shamik Parikh, MDSr. Director, Medical Science ) |
| Study ID Numbers: | D1690C00004 |
| Study First Received: | April 15, 2008 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00660907 History of Changes |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Dapagliflozin efficacy safety metformin Type 2 diabetes |
|
Hypoglycemic Agents Glipizide Metabolic Diseases Physiological Effects of Drugs Metformin |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |