Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+75 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Research Team
BS
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
Inclusion Criteria
Target Population
Signed Written Informed Consent
a) Subjects must be willing and able to give signed and dated written informed consent.
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Treatment Details
Interventions
- Dapagliflozin (Drug)
- Metformin IR (Drug)
- Placebo matching with Saxagliptin (Drug)
- Saxagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: Placebo+Dapagliflozin+Metformin IRExperimental Treatment3 Interventions
Group II: Arm 1: Saxagliptin+Dapagliflozin+Metformin IRExperimental Treatment3 Interventions
Dapagliflozin is already approved in Canada for the following indications:
Approved in Canada as Farxiga for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Research Advantage Inc/Desert Clinical Research LlcMesa, AZ
Cassidy Medical Group/Clinical Research AdvantageVista, CA
Infosphere Clinical Research, Inc.West Hills, CA
Clinical Therapeutics CorporationCoral Gables, FL
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Trials
4491
Patients Recruited
290,540,000+