Eirik Søfteland1, Juris J Meier2, Bente Vangen3, Robert Toorawa4, Mario Maldonado-Lutomirsky5, Uli C Broedl5. 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 withlinagliptin 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.
RCT Entities:
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.
Authors: E G Dorsey-Treviño; J G González-González; N Alvarez-Villalobos; V González-Nava; B M Contreras-Garza; A Díaz González-Colmenero; G Rodríguez-Tamez; F J Barrera-Flores; A M Farrell; V M Montori; R Rodriguez-Gutierrez Journal: J Endocrinol Invest Date: 2019-09-05 Impact factor: 4.256
Authors: Dimitrios A Vrachatis; Konstantinos A Papathanasiou; Konstantinos E Iliodromitis; Sotiria G Giotaki; Charalampos Kossyvakis; Konstantinos Raisakis; Andreas Kaoukis; Vaia Lambadiari; Dimitrios Avramides; Bernhard Reimers; Giulio G Stefanini; Michael Cleman; Georgios Giannopoulos; Alexandra Lansky; Spyridon G Deftereos Journal: Drugs Date: 2021-07-23 Impact factor: 9.546