Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial

Background:
To investigate the long-term efficacy and safety of empagliflozin monotherapy compared with placebo and sitagliptin in drug-naïve patients with type 2 diabetes mellitus.
Methods:
Of 899 patients randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, placebo, or sitagliptin 100 mg once daily for 24 weeks, 615 continued in a double-blind extension trial for ≥52 weeks. Exploratory endpoints included changes from baseline in HbA1c, weight and blood pressure at week 76.
Results:
Compared with placebo, adjusted mean changes from baseline in HbA1c at week 76 were −0.78 % (95 % CI −0.94, −0.63; p 

Source: Cardiovascular Diabetology - December 23, 2015 Category: Cardiology Authors: Michael RodenLudwig MerkerAnita ChristiansenFlavien RouxAfshin SalsaliGabriel KimPeter StellaHans WoerleUli BroedlOn behalf of the EMPA-REG EXTEND¿ MONO investigators Source Type: research