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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