Insulin degludec improves glycemic control with lower nocturnal hypoglycemia risk than insulin glargine: a 2-year randomized trial in type 1 diabetes — ASN Events
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Insulin degludec improves glycemic control with lower nocturnal hypoglycemia risk than insulin glargine: a 2-year randomized trial in type 1 diabetes (#45)

Bruce W Bode 1 , Simon Heller 2 , Charlotte T Hansen 3 , Denise Chang 4 , Shaun O'Mara 5 , David L Russell-Jones 6
  1. Atlanta Diabetes Associates, Atlanta, Georgia, USA
  2. School of Medicine and Biosciences, University of Sheffield, Sheffield, UK
  3. Novo Nordisk A/S, Søborg, Denmark
  4. Novo Nordisk, Princeton, New Jersey, USA
  5. Novo Nordisk, Baulkham Hills, NSW, Australia
  6. Department of Diabetes and Endocrinology, Royal Surrey County Hospital & University of Surrey, Guildford, UK

This 2-yr, open-label study compared efficacy and safety of insulin degludec (IDeg), a new, ultra-long-acting basal insulin, and insulin glargine (IGlar), in basal–bolus (BB) therapy in type 1 diabetes (T1DM).
The study comprised a 1-yr main period followed by 1-yr extension; subjects maintained prior randomization. Subjects were randomized 3:1 to IDeg or IGlar given subcutaneously once daily with mealtime insulin aspart. Basal insulin was titrated to target pre-breakfast plasma glucose (PG) (>3.9–<5.0mmol/L). Data at end of 2yrs of treatment (EOT) are presented.
Of 629 subjects (baseline: mean age 43yrs; diabetes duration 18.9yrs; HbA1c 7.7%; fasting PG 9.3mmol/L), 443 (IDeg: 330; IGlar: 113) completed 2yrs’ treatment. EOT HbA1c reduction was similar: –0.27% (IDeg) vs. –0.24% (IGlar); estimated treatment difference (ETD) IDeg–IGlar: −0.04% [95%CI −0.17;0.09], p=NS. Similar proportions of subjects achieved HbA1c<7% (IDeg: 34%; IGlar: 31%; p=NS). Rates of overall hypoglycemia (PG<3.1mmol/L or severe) were similar for entire period (37.5[IDeg] vs. 37.4[IGlar] episodes/pt-yr; estimated rate ratio [ERR] IDeg/IGlar: 1.02 [0.85;1.24]; p=NS) and maintenance period (16wk to EOT, when mean dose and glycemia stabilized; 34.0 vs. 35.0 episodes/pt-yr; ERR: 0.98 [0.80;1.20]; p=NS). Nocturnal hypoglycemia was significantly lower with IDeg (3.9 vs. 5.3 episodes/pt-yr; ERR: 0.75 [0.59;0.95]; p=0.02). Therefore, treating one patient for ~9 months with IDeg will avoid one nocturnal hypoglycemic episode.
In conclusion, IDeg safely and effectively improves glycemic control with a lower risk of nocturnal hypoglycemia than IGlar when part of 2-yr BB therapy in T1DM. This furthermore provides evidence for the long-term safety of IDeg in T1DM.