A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes

Aim This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes. Methods Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to r...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2013-08, Vol.15 (8), p.721-728
Main Authors: Ferrannini, E., Seman, L., Seewaldt-Becker, E., Hantel, S., Pinnetti, S., Woerle, H. J.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Argentina - epidemiology
Benzhydryl Compounds - administration & dosage
Benzhydryl Compounds - adverse effects
BI 10773
Blood Glucose
Body Weight
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - epidemiology
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
empagliflozin
Europe - epidemiology
Female
FPG
Glucosides - administration & dosage
Glucosides - adverse effects
Glycated Hemoglobin A - metabolism
HbA1c
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Male
Metformin - administration & dosage
Middle Aged
Nasopharyngitis - chemically induced
Nasopharyngitis - epidemiology
Republic of Korea - epidemiology
Russia - epidemiology
SGLT2 inhibitor
Sodium-Glucose Transporter 2 - antagonists & inhibitors
Taiwan - epidemiology
Thirst
tolerability
Treatment Outcome
Ukraine - epidemiology
Urination Disorders - chemically induced
Urination Disorders - epidemiology
Weight Loss
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Summary:Aim This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes. Methods Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks. Results After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.12081