A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

• Status: Completed
• Trial end date: 2017-11-10
• Target enrollment: 0
• Participant gender: All

Summary

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin; Saxagliptin

Criteria

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

Inclusion Criteria:

• At least 18 years of age at screening

• HbA1c ≥ 8% and ≤ 12% at screening

• Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)

• Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks

• estimated glomerular filtration rate (eGFR) < 60 ml/ml/1.73m2

• Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

• Clinical diagnosis of Type 1 diabetes

• History of ketoacidosis

• Renal, hepatic or pancreatic disease

• Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

• Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min