Overview

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