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- Title
Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial ( EASE-1).
- Authors
Pieber, T. R.; Famulla, S.; Eilbracht, J.; Cescutti, J.; Soleymanlou, N.; Johansen, O. E.; Woerle, H. J.; Broedl, U. C.; Kaspers, S.
- Abstract
Aims To investigate the pharmacodynamics, efficacy and safety of empagliflozin as adjunct to insulin in patients with type 1 diabetes. Methods A total of 75 patients with glycated haemoglobin ( HbA1c) concentrations of ≥7.5 to ≤10.5% (≥58 to ≤91 mmol/mol) were randomized to receive once-daily empagliflozin 2.5 mg, empagliflozin 10 mg, empagliflozin 25 mg, or placebo as adjunct to insulin for 28 days. Insulin dose was to be kept as stable as possible for 7 days then adjusted, at the investigator's discretion, to achieve optimum glycaemic control. The primary exploratory endpoint was change from baseline in 24-h urinary glucose excretion ( UGE) on day 7. Results Empagliflozin significantly increased 24-h UGE versus placebo on days 7 and 28. On day 28, adjusted mean differences with empagliflozin versus placebo in changes from baseline in: HbA1c were −0.35 to −0.49% (−3.8 to −5.4 mmol/mol; all p < 0.05 vs. placebo); total daily insulin dose −0.07 to −0.09 U/kg (all p<0.05 vs placebo); and weight were −1.5 to −1.9 kg (all p < 0.001 vs. placebo). In the placebo, empagliflozin 2.5, 10 and 25 mg groups, respectively, adverse events were reported in 94.7, 89.5, 78.9 and 100.0% of patients, and the rate of symptomatic hypoglycaemic episodes with glucose ≤3.0 mmol/l not requiring assistance was 1.0, 0.4, 0.5 and 0.8 episodes per 30 days. Conclusions In patients with type 1 diabetes, empagliflozin for 28 days as adjunct to insulin increased UGE, improved HbA1c and reduced weight with lower insulin doses compared with placebo and without increasing hypoglycaemia.
- Subjects
EMPAGLIFLOZIN; INSULIN therapy; TREATMENT of diabetes; PHARMACODYNAMICS; GLYCOSYLATED hemoglobin; DRUG dosage; PLACEBOS
- Publication
Diabetes, Obesity & Metabolism, 2015, Vol 17, Issue 10, p928
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12494