Ulrik Pedersen-bjergaard, Denmark
Steno Diabetes Center Copenhagen Health promotion researchPresenter of 1 Presentation
COMPARISON OF INSULIN DEGLUDEC AND GLARGINE U100 IN PATIENTS WITH TYPE 1 DIABETES PRONE TO SEVERE NOCTURNAL HYPOGLYCAEMIA
- Rikke M. Agesen, Denmark
- Amra Alibegovic, Denmark
- Henrik U. Andersen, Denmark
- Henning Beck-nielsen, Denmark
- Peter Gustenhoff, Denmark
- Troels K. Hansen, Denmark
- Christoffer Hedetoft, Denmark
- Tonny Jensen, Denmark
- Claus B. Juhl, Denmark
- Andreas Kryger, Denmark
- Susanne S. Lerche, Denmark
- Kirsten Nørgaard, Denmark
- Hans-Henrik Parving, Denmark
- Anne L. Sørensen, Denmark
- Lise Tarnow, Denmark
- Birger Thorsteinsson, Denmark
- Ulrik Pedersen-bjergaard, Denmark
Abstract
Background and Aims
Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes. This study aimed to investigate whether insulin degludec in comparison with insulin glargine U100 is superior in limiting the occurence of nocturnal hypoglycaemia in patients prone to nocturnal severe hypoglycaemia.
Methods
Danish investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over study. Adult patients with type 1 diabetes and at least one episode of nocturnal severe hypoglycaemia during the preceding two years were included. A 1-year plus 1-year treatment period was specified, consisting of two 3-month run-in period, each followed by a 9-month maintenance period. The primary endpoint was number of nocturnal symptomatic hypoglycaemic episodes during the maintenance period, analysed by intention-to-treat.
Results
A total of 149 patients were randomised to insulin degludec or insulin glargine U100. When defining night-time from 00:00 to 05:59 treatment with insulin degludec resulted in a 28% (95%CI:5-45; p=0.02) and 37% (95%CI:16-53; p=0.002) relative risk reduction (RRR) of nocturnal symptomatic hypoglycaemia ≤3.9 mmol/L and ≤3.0 mmol/L, respectively, compared to insulin glargine U100. Similar results with insulin degludec was demonstrated when defining night-time from 23:00 to 06:59 with a 27% (95%CI: 8-43; p=0.01) and 34% (95%CI:18-48; p<0.001) RRR of nocturnal symptomatic hypoglycaemia ≤3.9 mmol/L and ≤3.0 mmol/L, respectively. No significant differences in glycaemic control between treatments.
Conclusions
Type 1 diabetes patients prone to nocturnal severe hypoglycaemia had lower rates of nocturnal hypoglycaemia with insulin degludec as compared to with insulin glargine U100. The difference was relatively greater with increased severity of nocturnal hypoglycaemia.