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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02551874
• Date of registration: 15/09/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, 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 With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy
• Date of first enrolment: October 20, 2015
• Target sample size: 650
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02551874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, Denmark, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United States

Contacts

• Name: AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Metformin

Drug: Dapagliflozin, Farxiga

Drug: Glargine insulin

Drug: Saxagliptin, Onglyza

Primary Outcome(s)

Mean Change From Baseline in HbA1c at Week 24 [Time Frame: Baseline and Week 24]

Secondary Outcome(s)

Change From Baseline in the Mean Value of 24-hour Glucose at Week 2 [Time Frame: Baseline and Week 2]

Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24 [Time Frame: Baseline and Week 24]

Mean Change From Baseline in Total Body Weight at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Subjects With Confirmed Hypoglycaemia at Week 24 [Time Frame: Baseline and Week 24]

Secondary ID(s)

CV181-369

2015-001702-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02551874