Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections.

Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased

Hypoglycemia With Empagliflozin Added toTitrated Multiple Daily Injections of Insulin in

Obese Inadequately Controlled Type 2 Diabetes

Featured Article:

Julio Rosenstock, Ante Jelaska, Guillaume Frappin, Afshin Salsali, Gabriel Kim, Hans J. Woerle, and Uli C. Broedl, on behalf of the EMPA-REG MDI Trial

Investigators

Diabetes Care Volume 37: 1815-1823

July, 2014

STUDY OBJECTIVE 

• To investigate the efficacy and safety of empagliflozin, added to multiple daily injections (MDI) of insulin in obese patients with type 2 diabetes mellitus (T2DM)

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

STUDY DESIGN AND METHODS

• Patients inadequately controlled on MDI insulin ± metformin were randomized and treated with once-daily empagliflozin 10 mg, empagliflozin 25 mg, or placebo for 52 weeks

• Insulin dose was to remain stable in weeks 1–18, was adjusted to meet glucose targets in weeks 19–40, and then remain stable in weeks 41–52

• Primary end point was change from baseline in HbA1c at week 18

• Secondary end points were changes from baseline in insulin dose, weight, and HbA1c at week 52

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

RESULTS

• Changes from baseline in HbA1c were –0.50 ± 0.05% for placebo versus –0.94 ± 0.05% and –1.02 ± 0.05% for empagliflozin 10 mg and empagliflozin 25 mg, respectively, at week 18

• At week 52, further reductions with insulin titration resulted in changes from baseline in HbA1c of –0.81 ± 0.08, –1.18 ± 0.08, and –1.27 ± 0.08% with placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively, and final HbA1c of 7.5, 7.2, and 7.1%, respectively

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

RESULTS

• More patients attained HbA1c <7% with empagliflozin versus placebo

• Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses and weight versus placebo at week 52

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823

CONCLUSIONS

• In obese, difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses, empagliflozin improved glycemic control and reduced weight without increasing hypoglycemia risk and with lower insulin requirements

Rosenstock J. et al. Diabetes Care 2014;37:1815-1823