Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: A pooled analysis of three randomized trials.

Romera, Irene and Gomis, Ramon and Crowe, Susan and de Pablo-Velasco, Perdo and Aranda, Unai and Garcia, Arantxa and Gijanovic Kis, Sanja and Naderali, Ebrahim (2016) Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: A pooled analysis of three randomized trials. Journal of Diabetes and its Complications, 30 (8). pp. 1571-1576. ISSN 1056-8727 (Accepted for Publication)

Text Empagliflozin%20in%20combination_A%20pooled%20analysis%20of%20three%20randomized%20trials_J%20Diabetes%20Complications_%202016%20Nov%20-%20Dec-1.docx - Accepted Version Download (86kB)

Abstract

Aims: This analysis aimed to evaluate the efficacy and safety of empagliflozin in combination therapy in patients <65, overweight/obese, and with uncontrolled T2DM.
Methods: Pooled analysis from three randomised phase III trials, in patients aged <65 years, with BMI 25-35 kg/m2, and HbA1c ≥8% at baseline. Patients (N=439) were randomized to placebo (n=138), empagliflozin 10 mg (n=160), or empagliflozin 25 mg (n=141) once daily for 24 weeks as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin.
Results: At week 24, adjusted mean (SE) changes from baseline in HbA1c were -0.19% (0.07) for placebo vs. -1.10% (0.07) and -1.10% (0.07) for empagliflozin 10 and 25 mg, respectively (both p<0.001). Adjusted mean (SE) changes from baseline in weight were -0.33 kg (0.21) for placebo vs. -1.94 kg (0.19) and -2.14 kg (0.20) for empagliflozin 10 and 25 mg, respectively (both p<0.001). Adverse events (AEs) were reported in 57.2% on placebo, 64.4% on empagliflozin 10 mg and 59.6% on empagliflozin 25 mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10 mg, and 5.0% on empagliflozin 25 mg.
Conclusions: In this specific population empagliflozin in combination therapy with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.

Item Type:	Article
Additional Information and Comments:	NOTICE: this is the author’s version of a work that was accepted for publication in Journal of Diabetes and its Complications. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Diabetes and its Complications 23rd July, 2016 DOI: 10.1016/j.jdiacomp.2016.07.016.
Keywords:	Oral agents, Type 2 diabetes, Obesity, Therapy, Glycemic control, HbA1c.
Faculty / Department:	Faculty of Human and Digital Sciences > School of Health and Sport Sciences
Depositing User:	Ebrahim Naderali
Date Deposited:	24 Feb 2017 14:42
Last Modified:	19 Apr 2018 14:39
URI:	https://hira.hope.ac.uk/id/eprint/1862

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