Empagliflozin (EMPA) Compared with Glimepiride (GLIM) as Add-On to Metformin (MET) for 4 Years in Patients with Type 2 Diabetes (T2DM)

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Author Block: MARTIN RIDDERSTRÅLE, KNUT ROBERT ANDERSEN, ROBERT TOORAWA, HANS J. WOERLE, AFSHIN SALSALI, Malmö, Sweden, Asker, Norway, Bracknell, United Kingdom, Ingelheim, Germany, Ridgefield, CT

In the EMPA-REG H2H-SU trial, given as add-on to MET, EMPA 25 mg led to significant reductions from baseline in mean HbA1c, weight and blood pressure (BP) vs. GLIM at week 104, with a low risk of hypoglycemia, in patients with T2DM. Patients could continue in a 104-week extension. Exploratory endpoints analyzed at week 208 were change from baseline in HbA1c, occurrence of confirmed hypoglycemic adverse events (AEs; glucose ≤70 mg/dL and/or requiring assistance), and changes from baseline in weight, systolic and diastolic BP (SBP and DBP).

Of 765 and 780 patients treated with EMPA and GLIM, 576 and 549, respectively, continued in the extension.

RESULTS

At week 208, EMPA reduced mean HbA1c vs. GLIM. Rescue therapy was given to 23.3% of patients on EMPA and 34.0% on GLIM (odds ratio: 0.56 [95% CI 0.45, 0.71]; p<0.001). EMPA significantly reduced mean weight, SBP and DBP vs. GLIM (LOCF). Confirmed hypoglycemic AEs were reported in 3.1% of patients on EMPA and 27.9% on GLIM (adjusted risk ratio: 0.112 [95% CI 0.074, 0.169]; p<0.001); 0 patients on EMPA and 5 (0.6%) on GLIM required assistance. AEs consistent with urinary tract infection were reported in 19.9% and 16.2% of patients, and AEs consistent with genital infection in 13.6% and 3.8%, on EMPA and GLIM, respectively.

CONCLUSION

To conclude, EMPA 25 mg for 208 weeks as add-on to MET led to greater reductions in HbA1c, weight and BP with a lower risk of hypoglycemia vs. GLIM.

Glimepiride 1-4 mg

(n=780)Empagliflozin 25 mg

(n=765)HbA1c (%)Baseline†7.92 (0.03)7.92 (0.03)Change from baseline at week 208‡-0.34 (0.03)-0.41 (0.03)Difference vs. glimepiride (95% CI)-0.07 (-0.17, -0.03)p-value0.15Change from baseline at week 208§-0.08 (0.06)-0.26 (0.05)Difference vs. glimepiride (95% CI)-0.18 (-0.33, -0.03)p-value0.02Weight (kg)Baseline†83.0 (0.7)82.5 (0.7)Change from baseline at week 208‡1.2 (0.1)-3.4 (0.1)Difference vs. glimepiride (95% CI)-4.6 (-5.0, -4.3)p-value<0.001SBP (mmHg)Baseline†133.5 (0.6)133.4 (0.6)Change from baseline at week 208‡2.5 (0.5)-2.9 (0.5)Difference vs. glimepiride (95% CI)-5.4 (-6.6, -4.1)p-value<0.001DBP (mmHg)Baseline†79.4 (0.3)79.5 (0.3)Change from baseline at week 208‡0.6 (0.3)−1.9 (0.3)Difference vs. glimepiride (95% CI)-2.5 (-3.3, -1.7)p-value<0.001Data in patients treated with ≥1 dose of study drug who had a baseline HbA1c measurement. Values after glucose-lowering rescue medication were excluded from analysis of HbA1c, weight, BP. Values after a change in anti-hypertensive medication were excluded from BP analyses

†Mean (SE).

‡Adjusted mean (SE) based on ANCOVA (with baseline HbA1c and baseline of the endpoint in question as linear covariates and baseline eGFR, region and treatment as fixed effects) with last observation carried forward imputation

§Adjusted mean (SE) based on mixed model repeated measures analysis (with baseline HbA1c as a linear covariate and baseline eGFR, region, treatment, visit, and visit by treatment interaction as fixed effects) based on observed cases; N analyzed was 761 for GLIM and 759 for EMPA.

Authors: MARTIN RIDDERSTRÅLE, KNUT ROBERT ANDERSEN, ROBERT TOORAWA, HANS J. WOERLE, AFSHIN SALSALI, Malmö, Sweden, Asker, Norway, Bracknell, United Kingdom, Ingelheim, Germany, Ridgefield, CT