A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Status:	Active, not recruiting
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 120
Updated:	1/25/2019
Start Date:	August 14, 2015
End Date:	August 15, 2019

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,
in addition to metformin, results in better glycemic control, as measured by HbA1c, over a
treatment period of 52 weeks, compared to the addition of glimepiride to metformin in
subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin
Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in
co-administration with dapagliflozin, added to current background therapy with metformin
compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week
52.

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

Inclusion Criteria:

- Subjects must be willing and able to give signed and dated written informed consent

- Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control

- Subjects should have been taking the same daily dose of metformin ≥ 1500 mg

- Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)

- Males and females, aged ≥18 years old at time of screening visit

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test

- WOCBP and males must agree to follow instructions for method(s) of contraception for
the duration of treatment with study drug

Exclusion Criteria:

- Clinical diagnosis of type I diabetes

- History of diabetic ketoacidosis

- Cardiovascular/vascular diseases within 3 months of the enrollment

- Renal disease

- Hepatic diseases

- History of, or currently, acute or chronic pancreatitis

- Hematological and oncological disease/conditions

- Patients who have contraindications to therapy being studied

- Patients on weight loss program(s)

- Replacement or chronic systemic corticosteroid therapy

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