Phase 4
Completed N=939
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Type 2 Diabetes Mellitus · Inadequate Glycaemic Control
Source: ClinicalTrials.gov NCT02471404 ↗
Enrolled (actual)
939
Serious AEs
10.3%
Results posted
Mar 2019
Primary outcomePrimary: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 — -0.82; -1.2; -0.99 HbA1c % — p=0.001
◆ Published Evidence
Established
73citations · ~9 / year
Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes.
Summary
This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
Linked Publications
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Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 |
-0.82; -1.2; -0.99 | 0.001 sig |
| SECONDARY Patients With at Least One Episode of Confirmed Hypoglycaemia |
0; 0.32; 4.21 | <0.001 sig |
| SECONDARY Change in Total Body Weight From Baseline at Week 52 |
-3.54; -3.15; 1.76 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 |
-1.62; -2.08; -1.49 | 0.374 |
| SECONDARY Time to Rescue |
NA; NA; NA | 0.777 |
| SECONDARY Number of Patients Rescued |
18.6; 8.3; 21.4 | — |
Eligibility Criteria
Inclusion Criteria: Main Inclusion Criteria:
- Is male or female and ≥18 and <75 years old at time of informed consent.
- Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
- Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
- Has a BMI of ≤45 kg/m2 at Enrolment visit.
- Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.
Main, Exclusion Criteria:
- Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
- Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
- Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
- Concomitant treatment with loop diuretics
Data sourced from ClinicalTrials.gov (NCT02471404) 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.