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 Con

• Status: Completed
• Trial end date: 2019-09-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Glimepiride; Metformin; Saxagliptin

Criteria

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