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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02419612
• Date of registration: 14/04/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin =1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
• Date of first enrolment: August 14, 2015
• Target sample size: 444
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02419612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Sweden, United Kingdom, United States

Key inclusion & 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



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

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Other: Placebo

Drug: Glimepiride

Drug: Saxagliptin

Drug: Dapagliflozin

Primary Outcome(s)

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 [Time Frame: Baseline and Week 52]

Secondary Outcome(s)

Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. [Time Frame: Up to Week 156]

Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period [Time Frame: Up to Week 52]

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156 [Time Frame: At Week 156]

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52 [Time Frame: At Week 52]

Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period. [Time Frame: Up to Week 156]

Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 [Time Frame: Baseline and Week 52]

Change From Baseline in Total Body Weight at Week 52 [Time Frame: Baseline and Week 52]

Secondary ID(s)

CV181-365

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02419612