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Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2.

Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).

Author information

1
MedStar Health Research Institute, Hyattsville, MD, USA.
2
AMCR Institute Inc., Escondido, CA, USA.
3
Department of Endocrinology, CHU Nantes, l'Institut du Thorax, Nantes, France.
4
WISDEM Centre, University Hospitals of Coventry and Warwickshire, Coventry, UK.
5
Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
6
University of Texas Southwestern Medical Center, Dallas, TX, USA.
7
Novo Nordisk A/S, Søborg, Denmark.
8
Scripps Whittier Diabetes Institute, San Diego, CA, USA.

Erratum in

Abstract

AIM:

To evaluate the efficacy and safety of adding insulin degludec (IDeg) to treatment in patients with type 2 diabetes receiving liraglutide and metformin and qualifying for treatment intensification because of inadequate glycaemic control.

METHODS:

In this 26-week, double-blind trial, patients who still had inadequate glycaemic control after a 15-week run-in period with initiation and dose escalation of liraglutide to 1.8 mg in combination with metformin (≥1500 mg) were randomized to addition of once-daily IDeg ('IDeg add-on to liraglutide' arm; n = 174) or placebo ('placebo add-on to liraglutide' arm; n = 172), with dosing of both IDeg and placebo based on titration guidelines.

RESULTS:

At 26 weeks, the mean change in glycated haemoglobin level was greater in the IDeg add-on to liraglutide arm (-1.04%) than in the placebo add-on to liraglutide arm (-0.16%; p < 0.0001). Similarly, the mean fasting plasma glucose reduction was greater, and self-measured plasma glucose values were lower at all eight time points, with IDeg add-on versus placebo add-on (both p < 0.0001). At 26 weeks, the IDeg dose was 51 U (0.54 U/kg). During the run-in period with liraglutide, body weight decreased by ∼3 kg in both groups. After 26 weeks, the mean change was +2.0 kg (IDeg add-on to liraglutide) and -1.3 kg (placebo add-on to liraglutide). Confirmed hypoglycaemia rates were low in both groups, although higher with IDeg than with placebo (0.57 vs. 0.12 episodes/patient-years of exposure; p = 0.0002). Nocturnal confirmed hypoglycaemia was infrequent in both groups, with no episodes of severe hypoglycaemia, and no marked differences in adverse events with either treatment approach.

CONCLUSION:

The addition of liraglutide and IDeg to patients sub-optimally treated with metformin and liraglutide and requiring treatment intensification was found to be effective and well-tolerated.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01664247.

KEYWORDS:

GLP-1; glycaemic control; type 2 diabetes

PMID:
26990378
PMCID:
PMC5074260
DOI:
10.1111/dom.12661
[Indexed for MEDLINE]
Free PMC Article

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