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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Other: Placebo; Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02419612

CV181-365

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

444 participants in 2 patient groups

Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo

Experimental group

Description:

Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally

Treatment:

Drug: Saxagliptin

Other: Placebo

Drug: Dapagliflozin

Glimepiride or Placebo

Experimental group

Description:

Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally

Treatment:

Drug: Glimepiride

Other: Placebo