Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Recruiting in Palo Alto (17 mi)
+69 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?
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
Research Team
AZ
Astra Zeneca
Principal Investigator
AstraZeneca
Eligibility Criteria
Inclusion Criteria
Women must not be breastfeeding
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
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Treatment Details
Interventions
- Dapagliflozin (Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor)
- Placebo matching with Dapagliflozin (Drug)
- Placebo matching with Saxagliptin (Drug)
- Placebo matching with Sitagliptin (Drug)
- Saxagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
- Sitagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: A2: Sitagliptin / placeboExperimental Treatment2 Interventions
Sitagliptin 100 mg and matching placebo 0 mg (once daily)
Group II: A1:Saxagliptin / Placebo + Dapagliflozin / PlaceboExperimental Treatment4 Interventions
Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SitePembroke Pines, FL
Research SiteCharlotte, NC
Research SiteBristol, TN
Research SitePasadena, TX
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Trials
4491
Patients Recruited
290,540,000+