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Randomized Controlled Trial
. 2020 May;22(5):873-878.
doi: 10.1111/dom.13957. Epub 2020 Jan 29.

A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice

Giorgio Sesti  1 , Lars Bardtrum  2 , Selcuk Dagdelen  3 , Natalie Halladin  2 , Martin Haluzík  4 , Petra Őrsy  2 , Martin Rodríguez  5 , Vanita R Aroda  6   7
Affiliations
Randomized Controlled Trial

A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice

Giorgio Sesti et al. Diabetes Obes Metab. 2020 May.

Abstract

This report presents the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as initial injectable therapy at 26 weeks in the 104-week DUAL VIII durability trial (NCT02501161). Participants (N = 1012) with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs) were randomized 1:1 to open-label IDegLira or IGlar U100. Visits were scheduled at weeks 1, 2, 4 and 12, and every 3 months thereafter. After 26 weeks, glycated haemoglobin (HbA1c) reductions were greater with IDegLira versus IGlar U100 (-21.5 vs. -16.4 mmol/mol [-2.0 vs. -1.5%]), as was the percentage of participants achieving HbA1c <53 mmol/mol (78.7% vs. 55.7%) and HbA1c targets without weight gain and/or hypoglycaemia. Estimated treatment differences for insulin dose (-13.01 U) and body weight change (-1.57 kg) significantly favoured IDegLira. The hypoglycaemia rate was 44% lower with IDegLira versus IGlar U100. Safety results were similar. In a trial resembling clinical practice, more participants receiving IDegLira than IGlar U100 met treatment targets, supporting use of IDegLira as an initial injectable therapy for people with T2D uncontrolled on OADs and eligible for insulin initiation.

Keywords: clinical trial; insulin degludec; liraglutide; type 2 diabetes.

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Conflict of interest statement

G.S. has received speaker/consulting honoraria from Novo Nordisk, Eli Lilly, AstraZeneca, Boehringer Ingelheim, Merck Sharp & Dohme, Sanofi, Amgen, Abbott, GlaxoSmithKline and Servier. L.B., N.H. and P.Ő. are employees and shareholders at Novo Nordisk A/S. S.D. has been involved in international randomized clinical trials with Novo Nordisk, Sanofi, Takeda, Astra Zeneca and advisory boards for Novo Nordisk, Sanofi, Astra Zeneca, Bristol Myers Squib, Boehringer İngelheim, Merck Sharp & Dohme, Novartis and Servier. M.H. has been involved in various advisory boards for Novo Nordisk, speaker panel and multinational trials with Novo Nordisk products. M.R. has served as an advisory board member for Novo Nordisk, GlaxoSmithKline, Sanofi, Eli Lilly, Bristol Myers Squib, Janssen Cilag, Boehringer Ingelheim and Astra Zeneca, a speaker at meetings organized by Eli Lilly, Novo Nordisk, Bristol Myers Squib, Astra Zeneca, Merck, Sharp & Dohme, GlaxoSmithKline, Craveri, Sanofi, Novartis and Boehringer Ingelheim, and principal investigator of trials for Eli Lilly, Novo Nordisk, Novartis, Icon, Bristol Myers Squib and Boehringer Ingelheim. V.A. has served as a consultant for Adocia, Astra Zeneca, BD, Novo Nordisk, Sanofi, Zafgen, her spouse is employed at Merck Research Laboratories, and she has received research support (to institution) from Astra Zeneca/BMS, Calibra, Eisai, Janssen, Novo Nordisk, Sanofi and Theracos.

Figures

Figure 1
Figure 1
Glycaemic control. A) Glycated haemoglobin (HbA1c) concentration over time and B) self‐measured blood glucose (SMBG) for dose adjustment. Data are observed means based on the full analysis set. Numbers of participants contributing to the data points appear in the bottom panel. CI, confidence interval; ETD, estimated treatment difference; IDegLira, insulin degludec/liraglutide; IGlar U100, insulin glargine 100 units/mL
Figure 2
Figure 2
Attainment of treatment targets with insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100). %, based on observed data. Odds ratios (ORs; IDegLira/IGlar U100) are from a logistic regression model with treatment, baseline glycated haemoglobin (HbA1c) group, pre‐trial OAD and region as factors and baseline HbA1c (and body weight for endpoints including “without weight gain”) as a covariate. *Statistically significant difference (in favour of IDegLira). aSevere or blood glucose‐confirmed (<3.1 mmol/L) symptomatic hypoglycaemia was based on hypoglycaemic episodes during a participant's last 12 weeks of treatment. CI, confidence interval; OAD, oral antidiabetic drug
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