Efficacy and safety of empagliflozin twice daily versus once daily in patients with type 2 diabetes inadequately controlled on metformin: a 16-week, randomized, placebo-controlled trial

Patients with type 2 diabetes mellitus (T2DM) with a glycated haemoglobin (HbA1c) level ≥7 and ≤10% were randomized to receive empagliflozin 12.5 mg twice daily (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once daily (n = 220), or placebo (n = 107) as add‐on to stable‐d...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2015-07, Vol.17 (7), p.699-702
Main Authors: Ross, S., Thamer, C., Cescutti, J., Meinicke, T., Woerle, H. J., Broedl, U. C.
Format: Article
Language:English
Subjects:
Adult
Antidiabetics
Benzhydryl Compounds - administration & dosage
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
empagliflozin
Fatty acids
Glucosides - administration & dosage
glycaemic control
Glycated Hemoglobin A - analysis
Hemoglobin
Humans
Hypoglycemic Agents - administration & dosage
Metformin
Metformin - administration & dosage
once daily
Placebos
Treatment Outcome
twice daily
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Summary:Patients with type 2 diabetes mellitus (T2DM) with a glycated haemoglobin (HbA1c) level ≥7 and ≤10% were randomized to receive empagliflozin 12.5 mg twice daily (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once daily (n = 220), or placebo (n = 107) as add‐on to stable‐dose metformin immediate release (IR) twice daily for 16 weeks. The primary endpoint was change from baseline in HbA1c at week 16. At week 16, change from baseline in HbA1c with empagliflozin twice daily was non‐inferior to empagliflozin once daily and vice versa. The adjusted mean (95% confidence interval) difference in change from baseline in HbA1c with empagliflozin 12.5 mg twice daily versus 25 mg once daily was −0.11% (−0.26, 0.03), and with empagliflozin 5 mg twice daily versus 10 mg once daily it was −0.02% (−0.16, 0.13). All empagliflozin regimens were well tolerated; thus, when used as add‐on to metformin IR in patients with T2DM, the therapeutic effect of empagliflozin twice‐daily and once‐daily regimens can be considered equivalent.
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.12469