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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)
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Aroda, V. R., Bailey, T. S., Cariou, B., Kumar, Sudhesh, Leiter, L. A., Raskin, P., Zacho, J., Andersen, T. H. and Philis-Tsimikas, A. (2016) 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). Diabetes, Obesity and Metabolism, 18 (7). pp. 663-670. doi:10.1111/dom.12661 ISSN 1462-8902.
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Official URL: http://dx.doi.org/10.1111/dom.12661
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.
| Item Type: | Journal Article | ||||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences > Translational & Experimental Medicine > Metabolic and Vascular Health (- until July 2016) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | Diabetes, Obesity and Metabolism | ||||||||
| Publisher: | Blackwell | ||||||||
| ISSN: | 1462-8902 | ||||||||
| Official Date: | July 2016 | ||||||||
| Dates: |
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| Volume: | 18 | ||||||||
| Number: | 7 | ||||||||
| Page Range: | pp. 663-670 | ||||||||
| DOI: | 10.1111/dom.12661 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||
| Description: | Errata: Corrigendum Volume 18, Issue 9, 952, Article first published online: 22 August 2016 |
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