A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
Completed · Phase 3
Conditions studied: Type 2 Diabetes Mellitus
In brief
This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.
Key facts
- Study ID
- NCT02551874
- Run by
- AstraZeneca
- People needed
- 650
- Starts
- 2015-10-20
- Expected to finish
- 2017-11-10
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years of age at screening
- HbA1c ≥ 8% and ≤ 12% at screening
- Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
- Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
- estimated glomerular filtration rate (eGFR) \< 60 ml/ml/1.73m2
- Body Mass Index ≤ 45.0 kg/m2
You may not qualify if…
- Clinical diagnosis of Type 1 diabetes
- History of ketoacidosis
- Renal, hepatic or pancreatic disease
- Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
- Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
Where it is running
- Research Site — Anaheim, California, United States
- Research Site — Los Angeles, California, United States
- Research Site — Miami, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — St. Petersburg, Florida, United States
- Research Site — Norcross, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Lexington, Kentucky, United States
- Research Site — Quincy, Massachusetts, United States
- Research Site — Beavercreek, Ohio, United States
- Research Site — Norman, Oklahoma, United States
- Research Site — Barto, Pennsylvania, United States
- Research Site — Columbia, South Carolina, United States
- Research Site — Bristol, Tennessee, United States
- Research Site — Kingsport, Tennessee, United States
- Research Site — Houston, Texas, United States
- Research Site — Mesquite, Texas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — Bountiful, Utah, United States
- Research Site — Karlovy Vary, Czechia
- Research Site — Olomouc, Czechia
- Research Site — Copenhagen, Denmark
- Research Site — Budapest, Hungary
- Research Site — Budapest, Hungary
Full record on ClinicalTrials.gov
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