Phase 3
Completed N=1,413
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01719003 ↗Enrolled (actual)
1,413
Serious AEs
1.8%
Results posted
Feb 2016
Primary outcomePrimary: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 — -2.08; -1.93; -2.07; -1.98 percentage of HbA1c — p=0.0056
Summary
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 |
-2.08; -1.93; -2.07; -1.98; -1.36; -1.35 | 0.0056 sig |
| SECONDARY FPG (Fasting Plasma Glucose) Change From Baseline at Week 24 |
-51.0; -44.0; -47.8; -45.5; -28.0; -32.9 | <0.0001 sig |
| SECONDARY Body Weight Change From Baseline at Week 24 |
-3.78; -3.04; -3.48; -2.77; -2.38; -2.39 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
- HbA1c >=7.5% and =58.5 mmol/mol and 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
- Any antidiabetic drug within 12 weeks prior to randomization
- Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
- Contraindications to metformin according to the local label
Data sourced from ClinicalTrials.gov (NCT01719003). 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.