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

@inproceedings{Roden2015SafetyTA,
  title={Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-na{\"i}ve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial},
  author={Michael Roden and Ludwig Merker and Anita Vedel Christiansen and Flavien Roux and Afshin Salsali and Gabriel Kim and Peter Stella and Hans J Woerle and Uli C. Broedl},
  booktitle={Cardiovascular diabetology},
  year={2015}
}
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… CONTINUE READING
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Empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a randomised, 24-week, double-blind, placebo-controlled, parallel group, trial with sitagliptin as active comparator

  • M Roden, J Weng, J Eilbracht, B Delafont, G Kim, HJ Woerle
  • Lancet Diabetes Endocrinol
  • 2013
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