Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial

Abstract

This study assessed the efficacy of insulin degludec/liraglutide (IDegLira) vs insulin glargine U100 (IGlar) across categories of baseline glycated haemoglobin (HbA1c; ≤7.5%, >7.5% to ≤8.5% and >8.5%), body mass index (BMI; <30, ≥30 to <35 and ≥35 kg/m2 ) and fasting plasma glucose (FPG; <7.2 and ≥7.2 mmol/L) in patients with type 2 diabetes (T2D) uncontrolled on basal insulin, using post hoc analyses of the DUAL V 26-week trial. With IDegLira, mean HbA1c was reduced across all baseline HbA1c (1.0%-2.5%), FPG (1.5%-1.9%) and BMI categories (1.8%-1.9%), with significantly greater reductions compared with IGlar U100. For all HbA1c, FPG and BMI categories, IDegLira resulted in weight loss and IGlar U100 in weight gain; hypoglycaemia rates were lower for IDegLira vs IGlar U100. More patients achieved HbA1c <7% with IDegLira than IGlar U100 across all HbA1c (59%-87% vs 31%-66%), FPG (71%-74% vs 40%-51%) and BMI categories (71%-73% vs 40%-54%). IDegLira improved glycaemic control and induced weight loss in patients with T2D previously uncontrolled on basal insulin, across the categories of baseline HbA1c, FPG or BMI that were tested.

Trial registration: ClinicalTrials.gov NCT01952145.

Keywords: IDegLira; body mass index; clinical trial; insulin therapy; type 2 diabetes.

Conflict of interest statement

I. L. has received research funding form Novo Nordisk, Pfizer, Merck, Novartis, GI Dynamics and has received publication support and/or other in‐kind services from Novo Nordisk, Boheringer Ingelheimer, Astra Zeneca and Sanofi. S. H. has received research support from Novo Nordisk, Sanofi, Merck, Abbott, Janssen and AstraZeneca, has served on an advisory panel for Novo Nordisk, Sanofi, Merck, AstraZeneca, Lilly/BI, Amgen, Abbott and Janssen, has served as a consultant for Novo Nordisk, Sanofi, Merck, Abbott, Janssen and AstraZeneca, and/or other in‐kind services for CIHR, CDA, and The Lawson Foundation. E. J. has served on advisory panels and/or speaker bureaus for Novo Nordisk, Lilly, AstraZeneca, Boehringer, MSD, Janssen, Roche and Novartis, is a board member for Novo Nordisk and Lilly, and has received research support from Novo Nordisk, Novartis, Gilead, Roche, Miltenyi Biotech, Biotest, Wacker Chemie, Fresenius, DFG, BMBF, EU, JDRF and VW‐Stiftung. K. C. is a Novo Nordisk employee. M. F. R. is a Novo Nordisk employee and shareholder. E. J. has received consultant fees from Amgen, AstraZeneca, Lilly, MSD and Novo Nordisk, has been a clinical investigator for AstraZeneca, Boehringer, GSK, Janssen, Lilly, MSD, Novo Nordisk and Pfizer, and has served on speaker bureaus for AstraZeneca, GSK, Lilly, MSD and Novo Nordisk.

© 2017 John Wiley & Sons Ltd.

Figures

Figure 1

Change in HbA1c and body weight with IDegLira across categories of baseline HbA1c (A and B), FPG (C and D) and BMI (E and F). Data based on the full analysis set, with missing data imputed by last observation carried forward. Data are mean values with ETD (95% confidence interval) based on analysis of covariance. For (A), (C) and (E) dotted line represents American Diabetes Association HbA1c target <7.0%

Figure 2

HbA1c responders with IDegLira vs IGlar U100 in patients stratified according to baseline A, HbA1c; B, FPG and C, BMI. Data are percentage of patients reaching HbA1c target <7% and composite endpoints at EOT, based on the full analysis set with missing data imputed by last observation carried forward. Hypoglycaemic events defined as patient unable to self‐treat and/or plasma glucose <3.1 mmol/L occurring during the last 12 weeks of treatment