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Sponsors and Collaborators: |
AstraZeneca Bristol-Myers Squibb |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00698932 |
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.
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, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week International, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise. |
Estimated Enrollment: | 530 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Saxagliptin
oral tablet, once daily for 24 weeks
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2: Placebo Comparator |
Drug: Placebo
oral tablet, once daily for 24 weeks
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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 Öhman, MD, PhD | AstraZeneca, Wilmington, USA |
Study Chair: | Deborah Price, MSc | AstraZeneca, Wilmington, USA |
Responsible Party: | AstraZeneca Pharmaceuticals ( Peter Öhman, MD, PhD, Medical Science Director ) |
Study ID Numbers: | D1680C00005 |
Study First Received: | June 16, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00698932 |
Health Authority: | China: State Food and Drug Administration; India: Drugs Controller General of India; Philippines: Bureau of Food and Drugs; South Korea: Korea Food and Drug Administration (KFDA) |
DPP-4 inhibitors HBA1c Incretins |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |