Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:January 2014

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A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS
-512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin
(Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of
this treatment will also be studied.


Inclusion Criteria:

- Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%

- Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening

- Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria:

- Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine
(Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females

- Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic
Blood Pressure (DBP) ≥ 100mmHg

- Hepatic disease

- Cardiovascular disease within 3 months
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Bristol, Tennessee 37620
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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