Phase 3
Completed N=650
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
Source: ClinicalTrials.gov NCT02551874 ↗Enrolled (actual)
650
Serious AEs
5.1%
Results posted
Sep 2018
Primary outcomePrimary: Mean Change From Baseline in HbA1c at Week 24 — -1.67; -1.54 % HbA1c — p=0.118
◆ Published Evidence
Emerging
18citations · ~3 / year
Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial.
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.
Linked Publications
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Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in HbA1c at Week 24 |
-1.67; -1.54 | 0.118 |
| SECONDARY Mean Change From Baseline in Total Body Weight at Week 24 |
-1.50; 2.14 | <0.001 sig |
| SECONDARY Percentage of Subjects With Confirmed Hypoglycaemia at Week 24 |
21.3; 38.4 | <0.001 sig |
| SECONDARY Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24 |
20.9; 13.1 | 0.008 sig |
| SECONDARY Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24 |
33.2; 33.5 | — |
| SECONDARY Change From Baseline in the Mean Value of 24-hour Glucose at Week 2 |
-48.53; -28.54 | <0.0001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02551874) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.