Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01719003 | Diabetes Mellitus, Type 2 | HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 baseline and 24 weeks | Empagliflozin 10 mg qd | -1.35 percentage of HbA1c (±0.08 Standard Error) |
| Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid | -2.08 percentage of HbA1c (±0.08 Standard Error) | |||
| Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid | -1.93 percentage of HbA1c (±0.08 Standard Error) | |||
| Empagliflozin 25 mg qd | -1.36 percentage of HbA1c (±0.08 Standard Error) | |||
| Empagliflozin 5 mg Bid + Metformin 1000 mg Bid | -2.07 percentage of HbA1c (±0.08 Standard Error) | |||
| Empagliflozin 5 mg Bid + Metformin 500 mg Bid | -1.98 percentage of HbA1c (±0.08 Standard Error) | |||
| Metformin 1000 mg Bid | -1.75 percentage of HbA1c (±0.09 Standard Error) | |||
| Metformin 500 mg Bid | -1.18 percentage of HbA1c (±0.08 Standard Error) | |||
| NCT01734785 | Diabetes Mellitus, Type 2 | HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment Baseline and 24 weeks | Empagliflozin 10 mg | -0.65 Percentage of HbA1c (±0.08 Standard Error) |
| Empagliflozin 25 mg | -0.56 Percentage of HbA1c (±0.08 Standard Error) | |||
| Placebo | 0.14 Percentage of HbA1c (±0.09 Standard Error) | |||
| NCT01947855 | Diabetes Mellitus, Type 2 | Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 | Empagliflozin 10 mg | -103.56 mg*h/dL (±14.24 Standard Error) |
| Empagliflozin 25 mg | -122.94 mg*h/dL (±14.35 Standard Error) | |||
| Placebo | -18.07 mg*h/dL (±13.89 Standard Error) | |||
| NCT02182830 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks baseline and 24 weeks | Empagliflozin 10 Mg-25mg | -0.71 percentage of glycated haemoglobin (±0.14 Standard Error) |
| Placebo | 0.07 percentage of glycated haemoglobin (±0.14 Standard Error) | |||
| NCT02414958 | Diabetes Mellitus, Type 1 | Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 Baseline to week 26 | Empagliflozin 10 mg | -0.44 Percentage (%) (±0.04 Standard Error) |
| Empagliflozin 25 mg | -0.44 Percentage (%) (±0.04 Standard Error) | |||
| Placebo Matching Empagliflozin | 0.09 Percentage (%) (±0.04 Standard Error) | |||
| NCT02414958 | Diabetes Mellitus, Type 1 | Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) ) Baseline to week 26 | Empagliflozin 10 mg | -0.43 Percentage (%) (±0.04 Standard Error) |
| Empagliflozin 25 mg | -0.42 Percentage (%) (±0.04 Standard Error) | |||
| Placebo Matching Empagliflozin | 0.09 Percentage (%) (±0.04 Standard Error) | |||
| NCT02453555 | Diabetes Mellitus, Type 2 | Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline) Baseline and 24 week | Empagliflozin 10 mg/Linagliptin 5 mg | -0.93 Percentage (%) (±0.06 Standard Error) |
| Linagliptin 5 mg + Placebo 10 mg | 0.21 Percentage (%) (±0.09 Standard Error) | |||
| NCT02489968 | Diabetes Mellitus, Type 2 | Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment Baseline and 24 week | Empagliflozin 10 mg + Linagliptin 5 mg | -0.94 Percentage (%) (±0.05 Standard Error) |
| Empagliflozin 10 mg + Placebo | -0.12 Percentage (%) (±0.06 Standard Error) | |||
| Empagliflozin 25 mg + Linagliptin 5 mg | -0.91 Percentage (%) (±0.05 Standard Error) | |||
| Empagliflozin 25 mg + Placebo | -0.33 Percentage (%) (±0.05 Standard Error) | |||
| NCT02580591 | Diabetes Mellitus, Type 1 | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) Baseline to week 26 | Empagliflozin 10 mg | -0.25 Percentage (%) (±0.05 Standard Error) |
| Empagliflozin 2.5 Milligram (mg) | -0.09 Percentage (%) (±0.05 Standard Error) | |||
| Empagliflozin 25 mg | -0.33 Percentage (%) (±0.05 Standard Error) | |||
| Placebo Matching Empagliflozin | 0.20 Percentage (%) (±0.05 Standard Error) | |||
| NCT02580591 | Diabetes Mellitus, Type 1 | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) Baseline to week 26 | Empagliflozin 10 mg | -0.23 Percentage (%) (±0.05 Standard Error) |
| Empagliflozin 2.5 Milligram (mg) | -0.06 Percentage (%) (±0.05 Standard Error) | |||
| Empagliflozin 25 mg | -0.30 Percentage (%) (±0.05 Standard Error) | |||
| Placebo Matching Empagliflozin | 0.21 Percentage (%) (±0.05 Standard Error) | |||
| NCT02863328 PIONEER 2 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 26 | Empagliflozin 25 mg | -0.9 Percentage-point of HbA1c (±0.9 Standard Deviation) |
| Empagliflozin 25 mg | -0.9 Percentage-point of HbA1c (±0.9 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.3 Percentage-point of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.5 Percentage-point of HbA1c (±1.1 Standard Deviation) | |||
| NCT03057951 | Heart Failure | Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) From randomization until completion of the planned treatment phase, up to 1403 days. | 10 mg Empagliflozin | 6.86 Patients with event/100 pt-yrs at risk |
| Placebo | 8.67 Patients with event/100 pt-yrs at risk | |||
| NCT03057977 | Heart Failure | Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) From randomisation until completion of the planned treatment period, up to 1040 days. | 10 mg Empagliflozin | 15.77 Patients with events/ 100 pt-yrs at risk |
| Placebo | 21.00 Patients with events/ 100 pt-yrs at risk | |||
| NCT03087773 EMMY | Heart Failure | Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels 26 weeks | Empagliflozin | -84.9 pg/mL |
| Placebo Oral Tablet | -82.2 pg/mL | |||
| NCT03332212 | Heart Failure | Change From Baseline to Week 12 in PCr/ATP Ratio in the Resting State Measured by 31P Cardiac Magnetic Resonance Spectroscopy (MRS). At baseline and at week 12. | Empagliflozin 10mg Cohort A | -0.179 PCr / ATP Ratio (±0.117 Standard Error) |
| Empagliflozin 10mg Cohort B | 0.100 PCr / ATP Ratio (±0.143 Standard Error) | |||
| Placebo Cohort A | 0.068 PCr / ATP Ratio (±0.114 Standard Error) | |||
| Placebo Cohort B | 0.259 PCr / ATP Ratio (±0.156 Standard Error) | |||
| NCT03351478 SOTA-EMPA | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26 Baseline, Week 26 | Empagliflozin 25 mg | -0.8 percentage of HbA1c (±0.1 Standard Error) |
| Placebo | -0.3 percentage of HbA1c (±0.1 Standard Error) | |||
| Sotagliflozin 400 mg | -0.7 percentage of HbA1c (±0.1 Standard Error) | |||
| NCT03429543 | Diabetes Mellitus, Type 2 | Change in Glycated Haemoglobin (HbA1c) (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ Baseline (Day 1) and week 26 of treatment. | Empagliflozin 10 mg - DINAMOᵀᴹ & Empagliflozin 10 - 25 mg - DINAMOᵀᴹ (TG2) | 0.14 Percent change |
| Empagliflozin 10 mg - DINAMOᵀᴹ (TG3) | -0.49 Percent change | |||
| Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ (TG1) | -0.17 Percent change | |||
| Linagliptin 5 mg - DINAMOᵀᴹ (TG1) | 0.33 Percent change | |||
| Placebo - DINAMOᵀᴹ (TG1, TG2 & TG3) | NA Percent change | |||
| NCT03429543 | Diabetes Mellitus, Type 2 | Percentage of Patients With Treatment Failure up to or at Week 26 Up to 26 weeks. | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | 50.0 Percentage of subjects |
| Linagliptin 5 mg - DINAMOᵀᴹ Mono | 50.0 Percentage of subjects | |||
| Placebo - DINAMOᵀᴹ Mono | 60.0 Percentage of subjects | |||
| NCT03448406 | Heart Failure | Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD) At baseline and at Week 12 | 10 mg Empagliflozin | 10.0 Meter (m) |
| Placebo | 5.0 Meter (m) | |||
| NCT03448419 | Heart Failure | Change From Baseline to Week 12 in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance At baseline and at week 12 | 10 mg Empagliflozin | 13.5 Meter (m) |
| Placebo | 18.0 Meter (m) | |||
| NCT03594110 | Renal Insufficiency, Chronic | Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days. | Empagliflozin 10 mg | 6.85 patients with events/100 pt-yrs at risk |
| Placebo | 8.96 patients with events/100 pt-yrs at risk | |||
| NCT03594110 | Renal Insufficiency, Chronic | Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Empagliflozin 10 mg | 8.36 patients with events/100 pt-yrs at risk |
| Placebo | 9.99 patients with events/100 pt-yrs at risk | |||
| NCT04157751 | Heart Failure | Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment Up to 90 days. For KCCQ-TSS: at baseline and at day 90. | 10 mg Empagliflozin | 7.15 pct. (%) of winning pairwise comparisons |
| 10 mg Empagliflozin | 10.59 pct. (%) of winning pairwise comparisons | |||
| 10 mg Empagliflozin | 0.24 pct. (%) of winning pairwise comparisons | |||
| 10 mg Empagliflozin | 35.91 pct. (%) of winning pairwise comparisons | |||
| Placebo | 4.01 pct. (%) of winning pairwise comparisons | |||
| Placebo | 7.65 pct. (%) of winning pairwise comparisons | |||
| Placebo | 27.48 pct. (%) of winning pairwise comparisons | |||
| Placebo | 0.57 pct. (%) of winning pairwise comparisons | |||
| NCT04233801 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24 At baseline (Week 0) and at Week 24 | Empagliflozin 10 mg | -1.12 Percentage of glycosylated hemoglobin (±0.10 Standard Error) |
| Empagliflozin 25 mg | -1.12 Percentage of glycosylated hemoglobin (±0.10 Standard Error) | |||
| Placebo | -0.13 Percentage of glycosylated hemoglobin (±0.10 Standard Error) | |||
| NCT04509674 | Myocardial Infarction | Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days. | Empagliflozin 10 mg | 5.85 Pt with events/100 pt-years at risk |
| Placebo | 6.58 Pt with events/100 pt-years at risk |