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Erschienen in: Advances in Therapy 6/2014

01.06.2014 | Original Research

Empagliflozin Monotherapy in Japanese Patients with Type 2 Diabetes Mellitus: a Randomized, 12-Week, Double-Blind, Placebo-Controlled, Phase II Trial

verfasst von: Takashi Kadowaki, Masakazu Haneda, Nobuya Inagaki, Yasuo Terauchi, Atsushi Taniguchi, Kazuki Koiwai, Henning Rattunde, Hans J. Woerle, Uli C. Broedl

Erschienen in: Advances in Therapy | Ausgabe 6/2014

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Abstract

Introduction

This study was designed to determine the efficacy and tolerability of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus (T2DM).

Methods

Patients with glycosylated hemoglobin (HbA1c) ≥7.0–≤10% were randomized via an interactive web response system, and treated double-blind with empagliflozin 5, 10, 25, 50 mg, or placebo once daily for 12 weeks. The primary endpoint was change from baseline in HbA1c at week 12. Other endpoints included percentage of patients with HbA1c <7.0% and changes from baseline in fasting plasma glucose (FPG), body weight, and systolic blood pressure (SBP) at week 12.

Results

A total of 547 patients were randomized and treated with empagliflozin 5 mg (n = 110), 10 mg (n = 109), 25 mg (n = 109), 50 mg (n = 110), or placebo (n = 109) for 12 weeks. Adjusted mean [95% confidence interval (CI)] differences vs. placebo in changes from baseline in HbA1c were −0.72% (−0.87, −0.57) with empagliflozin 5 mg, −0.70% (−0.85, −0.55) with 10 mg, −0.95% (−1.10, −0.80) with 25 mg, and −0.91 (−1.06, −0.76) with 50 mg (all p < 0.001). More patients with HbA1c ≥7.0% at baseline reached HbA1c <7.0% with empagliflozin (19–33%) than placebo (3%). Compared with placebo, empagliflozin reduced FPG, body weight (p < 0.001 for all doses for both endpoints) and SBP (p = 0.001, p = 0.014 and p = 0.003 for empagliflozin 10, 25, and 50 mg, respectively). Adverse events were reported by 42% of patients receiving placebo and 33–38% of patients receiving empagliflozin. There were few reports of confirmed hypoglycemic adverse events or events consistent with urinary tract infection or genital infection in any treatment group.

Conclusions

Empagliflozin monotherapy for 12 weeks in Japanese patients with T2DM reduced HbA1c, FPG, body weight and SBP, and was well tolerated.
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Metadaten
Titel
Empagliflozin Monotherapy in Japanese Patients with Type 2 Diabetes Mellitus: a Randomized, 12-Week, Double-Blind, Placebo-Controlled, Phase II Trial
verfasst von
Takashi Kadowaki
Masakazu Haneda
Nobuya Inagaki
Yasuo Terauchi
Atsushi Taniguchi
Kazuki Koiwai
Henning Rattunde
Hans J. Woerle
Uli C. Broedl
Publikationsdatum
01.06.2014
Verlag
Springer Healthcare
Erschienen in
Advances in Therapy / Ausgabe 6/2014
Print ISSN: 0741-238X
Elektronische ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-014-0126-8

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