Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Pieber, TR; Famulla, S; Eilbracht, J; Cescutti, J; Soleymanlou, N; Johansen, OE; Woerle, HJ; Broedl, UC; Kaspers, S.
Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1).
Diabetes Obes Metab. 2015; 17(10):928-935
Doi: 10.1111/dom.12494
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- Führende Autor*innen der Med Uni Graz
- Pieber Thomas
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- Abstract:
- To investigate the pharmacodynamics, efficacy and safety of empagliflozin as adjunct to insulin in patients with type 1 diabetes. 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. 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. 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. © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Austria -
- Benzhydryl Compounds - administration & dosage
- Diabetes Mellitus, Type 1 - blood
- Diabetes Mellitus, Type 1 - drug therapy
- Diabetes Mellitus, Type 1 - urine
- Dose-Response Relationship, Drug -
- Double-Blind Method -
- Drug Therapy, Combination -
- Female -
- Germany -
- Glucosides - administration & dosage
- Glycated Hemoglobin A - drug effects
- Glycosuria - urine
- Humans -
- Hypoglycemia - chemically induced
- Hypoglycemic Agents - administration & dosage
- Insulin - administration & dosage
- Male -
- Middle Aged -
- Treatment Outcome -
- Weight Loss - drug effects
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- pharmacodynamics
- pharmacology
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- type 1 diabetes