Overview

This trial has been completed.

Condition type 2 diabetes
Treatments saxagliptin, dapagliflozin, sitagliptin, placebo matching with saxagliptin, placebo matching with dapagliflozin, placebo matching with sitagliptin
Phase phase 3
Sponsor AstraZeneca
Start date September 2014
End date September 2016
Trial size 838 participants
Trial identifier NCT02284893, 2014-001102-17, CV181-363

Summary

A combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)
saxagliptin
administered orally once daily
dapagliflozin
administered orally once daily
placebo matching with saxagliptin
administered orally once daily
placebo matching with dapagliflozin
administered orally once daily
(Experimental)
Sitagliptin 100 mg and matching placebo 0 mg (once daily)
sitagliptin
administered orally once daily
placebo matching with sitagliptin
administered orally once daily

Primary Outcomes

Measure
Mean change in HbA1c
time frame: Baseline (randomization) to Week 26

Secondary Outcomes

Measure
Percent of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%
time frame: Week 26
Mean change in total body weight
time frame: Baseline (randomization) to Week 26
Mean change in Fasting Plasma Glucose (FPG)
time frame: Baseline (randomization) to Week 26

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit - Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening - BMI > 20.0 kg/m2 at the enrollment visit - Males and Females, age ≥18 years old at time of screening visit - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug - Women must not be breastfeeding Exclusion Criteria: - Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus - History of diabetic ketoacidosis - Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit - Myocardial infarction - Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty [(PTCA)]) - Unstable angina - Unstable congestive heart failure (CHF) - Transient ischemic attack (TIA) or significant cerebrovascular disease - Unstable or previously undiagnosed arrhythmia - Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40% - Renal Disease - Hepatic Diseases - Hematological and Oncological Disease/Conditions - Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women - Abnormal Free T4

Additional Information

Official title A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.