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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02419612

Run by

AstraZeneca

People needed

444

Starts

2015-08-14

Expected to finish

2019-09-18

Last updated by the study team

2020-06-23

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Chandler, Arizona, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Huntington Park, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Tarzana, California, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Edina, Minnesota, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Greer, South Carolina, United States
• Research Site — Bristol, Tennessee, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Cheb, Czechia
• Research Site — Hradec Králové, Czechia
• Research Site — Krnov, Czechia
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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