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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 120
Updated:12/13/2018
Start Date:October 20, 2015
End Date:November 10, 2017

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A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, 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 With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy

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.

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the
Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in
Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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