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Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial.

Author information

1
Haukeland University Hospital, Bergen, Norway eirik.softeland.med@helse-bergen.no.
2
Ruhr-Universität Bochum, Bochum, Germany.
3
Boehringer Ingelheim Norway KS, Asker, Norway.
4
Boehringer Ingelheim Ltd., Bracknell, Berkshire, U.K.
5
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of empagliflozin versus placebo as add-on therapy in patients with type 2 diabetes and inadequate glycemic control with linagliptin and metformin.

RESEARCH DESIGN AND METHODS:

Patients with HbA1c ≥8.0% and ≤10.5% (≥64 and ≤91 mmol/mol) while receiving stable-dose metformin received open-label linagliptin 5 mg (n = 606) for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (≥53 and ≤91 mmol/mol) were randomized to receive double-blind, double-dummy treatment with empagliflozin 10 mg (n = 112), empagliflozin 25 mg (n = 111), or placebo (n = 110) for 24 weeks; all patients continued treatment with metformin and linagliptin 5 mg. The primary end point was the change from baseline in HbA1c after 24 weeks of double-blind treatment.

RESULTS:

At week 24, empagliflozin significantly reduced HbA1c (mean baseline 7.96-7.97% [63-64 mmol/mol]) versus placebo; the adjusted mean differences in the change from baseline with empagliflozin 10 and 25 mg versus placebo were -0.79% (95% CI ‒1.02, ‒0.55) (-8.63 mmol/mol [‒11.20, ‒6.07 mmol/mol]) and -0.70% (95% CI ‒0.93, ‒0.46) (-7.61 mmol/mol [‒10.18, ‒5.05 mmol/mol]), respectively (both P < 0.001). Fasting plasma glucose and weight were significantly reduced in both empagliflozin groups versus placebo (P < 0.001 for all comparisons). More patients receiving placebo than empagliflozin 10 and 25 mg reported adverse events during double-blind treatment (68.2%, 55.4%, and 51.8%, respectively).

CONCLUSIONS:

Empagliflozin treatment for 24 weeks improved glycemic control and weight versus placebo as an add-on to linagliptin 5 mg and metformin and was well tolerated.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01734785.

PMID:
27913576
DOI:
10.2337/dc16-1347
[Indexed for MEDLINE]

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