Format

Send to

Choose Destination
Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.

Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials.

Author information

1
Royal Surrey County Hospital, University of Surrey, Guildford, UK. Electronic address: Davidrussell-jones@nhs.net.
2
Novo Nordisk A/S, Soeborg, Denmark.
3
Novo Nordisk, Mainz, Germany.
4
VU University Medical Center, Amsterdam, The Netherlands.
5
University of Pisa, Pisa, Italy.

Abstract

BACKGROUND AND AIMS:

Basal insulin analogues have a reduced risk of hypoglycaemia compared with NPH insulin, but hypoglycaemia still remains a major impediment to achieving recommended fasting plasma glucose (FPG) targets in patients with diabetes. Insulin degludec (IDeg) is a new basal insulin that forms soluble multihexamers after subcutaneous injection resulting in an ultra-long duration of action and stable glucose-lowering effect. The aim of this analysis was to compare the effect of IDeg on FPG and nocturnal confirmed hypoglycaemia as compared to insulin glargine (IGlar).

METHODS AND RESULTS:

Data were included from seven phase 3a, randomised, open-label, treat-to-target clinical trials in which once-daily IDeg was compared with once-daily IGlar. Two trials included a total of 957 patients with type 1 diabetes (T1D) and five trials included a total of 3360 patients with type 2 diabetes (T2D); all trials were 26 or 52 weeks in duration. Confirmed hypoglycaemia was defined as plasma glucose <3.1 mmol/L or severe episodes requiring assistance, and nocturnal hypoglycaemia occurred between 00:01 and 05:59. In all trials, the mean end-of-trial FPG was lower for IDeg than IGlar, reaching statistical significance in three trials. Similarly, IDeg was associated with a lower rate of nocturnal confirmed hypoglycaemia vs. IGlar, which was statistically significant in three trials, regardless of type of diabetes or background therapy.

CONCLUSION:

This analysis shows that the lower rate of nocturnal confirmed hypoglycaemia seen with IDeg relative to IGlar is accompanied by a reduced mean FPG, in particular in patients with T2D.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00972283 NCT00982228 NCT00982644 NCT01006291 NCT01059799 NCT01068665 NCT01079234.

KEYWORDS:

Diabetes; Fasting plasma glucose; Hypoglycaemia; Insulin therapy; Meta-analysis

PMID:
26232910
DOI:
10.1016/j.numecd.2015.06.005
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center