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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Saxagliptin, Onglyza; Drug: Glargine insulin; Drug: Dapagliflozin, Farxiga

Study type: Interventional

Funder types: Industry

Identifiers

NCT02551874

2015-001702-33 (EudraCT Number)

CV181-369

Details and patient eligibility

About

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.

Full description

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Enrollment: 650 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Saxagliptin/Dapagliflozin/Metformin

Experimental group

Description:

Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin

Treatment:

Drug: Dapagliflozin, Farxiga

Drug: Saxagliptin, Onglyza

Drug: Metformin

Insulin Glargine, Lantos/Metformin

Active Comparator group

Description:

Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.

Treatment:

Drug: Glargine insulin