Empagliflozin as add‐on to metformin in people with Type 2 diabetes

L. Merker; H‐U. Häring; A. V. Christiansen; F. Roux; A. Salsali; G. Kim; T. Meinicke; H. J. Woerle; U. C. Broedl

doi:10.1111/dme.12814

journal article Jul 14, 2015

Empagliflozin as add‐on to metformin in people with Type 2 diabetes

L. Merker H‐U. Häring A. V. Christiansen F. Roux A. Salsali G. Kim T. Meinicke H. J. Woerle U. C. Broedl

Diabetic Medicine Vol. 32 No. 12 pp. 1555-1567 · Wiley

View at Publisher Save 10.1111/dme.12814

Abstract

AbstractAimsTo investigate the long‐term efficacy and safety of empagliflozin as add‐on to metformin in people with Type 2 diabetes.MethodsOf 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double‐blind extension trial for ≥ 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA1c, weight and blood pressure at week 76.ResultsCompared with placebo, adjusted mean changes from baseline in HbA1c (overall baseline mean ± sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were −7 mmol/mol [(−0.6%) 95% CI −8, −5 mmol/mol (−0.8, −0.5%); P < 0.001] and −8 mmol/mol [(−0.7%) 95% CI −10, −6 mmol/mol (−0.9, −0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were −1.9 kg (95% CI −2.5, −1.3; P < 0.001) and −2.2 kg (95% CI −2.8, −1.6; P < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose ≤ 3.9 mmol/l and/or event requiring assistance) were reported in 3.4, 4.1 and 4.2% of participants in these groups, respectively.ConclusionsIn people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add‐on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA1c, weight and systolic blood pressure.

Topics

No keywords indexed for this article. Browse by subject →

References

24

[1]

10.1111/j.1463-1326.2011.01517.x

[2]

10.1016/j.diabres.2014.02.014

[3]

10.1111/dom.12073

[4]

Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial

Michael Roden, Jianping Weng, Jens Eilbracht et al.

The Lancet Diabetes & Endocrinology 10.1016/s2213-8587(13)70084-6

[5]

10.1016/s2213-8587(13)70208-0

[6]

10.2337/dc13-2105

[7]

10.2337/dc12-2673

[8]

10.1111/dom.12188

[9]

10.2337/dc13-3055

[10]

10.1016/s2213-8587(14)70120-2

[11]

10.2337/dc12-0413

[12]

10.1001/jama.281.21.2005

[13]

10.1016/j.jdiacomp.2013.04.012

[14]

10.1185/03007995.2014.890925

[15]

10.1111/dom.12307

[16]

10.2337/dc13-0663

[17]

10.1111/dom.12185

[18]

10.1172/jci72227

[19]

10.1016/j.jash.2014.01.007

[20]

10.1161/circulationaha.113.005081

[21]

10.1186/1741-7015-11-43

[22]

10.2337/dc13-2762

[23]

10.1111/dom.12187

[24]

10.1111/j.1463-1326.2010.01204.x

Cited By

73

Sodium‐Glucose Cotransporter 2 Inhibitors, All‐Cause Mortality, and Cardiovascular Outcomes in Adults with Type 2 Diabetes: A Bayesian Meta‐Analysis and Meta‐Regression

Ayodele Odutayo, Bruno R. da Costa · 2021

Journal of the American Heart Assoc...

Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus

Ona Kinduryte Schorling, Douglas Clark · 2020

Advances in Therapy

Incretin mimetics and sodium-glucose co-transporter 2 inhibitors as monotherapy or add-on to metformin for treatment of type 2 diabetes: a systematic review and network meta-analysis

Shubing Jia, Zhiying Wang · 2020

Acta Diabetologica

Empagliflozin: A Review in Type 2 Diabetes

James E. Frampton · 2018

Drugs

Efficacy and safety of empagliflozin as add-on to metformin for type 2 diabetes: a systematic review and meta-analysis

Xiaoyan Zhong, Dan Lai · 2016

European Journal of Clinical Pharma...

Metrics

73

Citations

24

References

Details

Published: Jul 14, 2015
Vol/Issue: 32(12)
Pages: 1555-1567
License: View

Authors

L

L. Merker

Diabetes‐ und Nierenzentrum Dormagen Germany

H

H‐U. Häring

University of Tübingen Tübingen Germany

A

A. V. Christiansen

Boehringer Ingelheim Danmark A/S Copenhagen Denmark

F

F. Roux

Boehringer Ingelheim France S.A.S. Reims France

A

A. Salsali

Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield CT USA

G

G. Kim

Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany

T

T. Meinicke

Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany

H

H. J. Woerle

Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany

U

U. C. Broedl

Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany

Funding

Boehringer Ingelheim

Eli Lilly and Company

Cite This Article

L. Merker, H‐U. Häring, A. V. Christiansen, et al. (2015). Empagliflozin as add‐on to metformin in people with Type 2 diabetes. Diabetic Medicine, 32(12), 1555-1567. https://doi.org/10.1111/dme.12814

Empagliflozin as add‐on to metformin in people with Type 2 diabetes

You May Also Like