The Effect of Insulin Degludec on Glycemic Control and Nocturnal Hypoglycemia Compared with Insulin Glargine: A 1-year Randomized Trial in Insulin-naïve People with Type 2 Diabetes — ASN Events
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The Effect of Insulin Degludec on Glycemic Control and Nocturnal Hypoglycemia Compared with Insulin Glargine: A 1-year Randomized Trial in Insulin-naïve People with Type 2 Diabetes (#293)

Bernard Zinman 1 , Athena Philis-Tsimikas 2 , Yehuda Handelsman 3 , Helena W Rodbard 4 , Bertrand Cariou 5 , Thue Johansen 6 , Lars Endahl 6 , John Miller 7 , Chantal Mathieu 8
  1. Mount Sinai Hospital, Toronto, Ontario, Canada
  2. Scripps Whittier Diabetes Institute, La Jolla, California, USA
  3. Metabolic Institute of America, Tarzana, California, USA
  4. Endocrine and Metabolic Consultants, MD, USA, Rockville, Maryland, USA
  5. Department of Endocrinology, Nantes University Hospital, Nantes, France
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Novo Nordisk, Baulkham Hills, NSW, Australia
  8. Katholieke Universitet Leuven, Leuven, Belgium

Insulin degludec (IDeg) is a novel basal insulin with an ultra-long, flat action profile. This 52-wk randomized, open-label, non-inferiority, treat-to-target trial compared efficacy and safety of IDeg to insulin glargine (IGlar) given once daily in insulin-naïve type 2 diabetes subjects inadequately controlled with OADs (metformin±DPP-4 inhibitor). 1030 adults (mean age 59.1 yrs; diabetes duration 9.2 yrs; HbA1c 8.2%; fasting plasma glucose [FPG] 9.7 mmol/L) were randomized 3:1 to IDeg or IGlar. Both basal insulins were titrated to blood glucose targets of 3.9-4.9 mmol/L. Completion rates were 79% (IDeg) and 77% (IGlar). IDeg reduced HbA1c (-1.06%) non-inferior to IGlar (-1.19%) (estimated treatment difference [ETD] IDeg-IGlar: 0.09% [95%CI: -0.04; 0.22]). FPG reductions were significantly larger with IDeg than IGlar (-3.76 vs -3.30 mmol/L; ETD: -0.43 mmol/L [95%CI: -0.74; -0.13]; p=0.005). Overall confirmed hypoglycemia (PG <3.1 mmol/L and severe requiring assistance) rates were similar for IDeg and IGlar (1.52 vs 1.85 episodes/patient-yr; estimated rate ratio [ERR] IDeg:IGlar: 0.82 [95%CI: 0.64; 1.04]; p=0.11). Nocturnal confirmed hypoglycemia rates were significantly 36% lower with IDeg (0.25 vs 0.39 episodes/patient-yr; ERR: 0.64 [95%CI: 0.42; 0.98]; p=0.04). Overall severe hypoglycemia was significantly lower with IDeg (0.003 vs 0.023 episodes/patient-yr; ERR: 0.14 [95%CI: 0.03; 0.70]; p=0.02). End-of-trial mean daily insulin doses were 0.59 (IDeg) and 0.60 (IGlar) U/kg. Mean weight gain was similar: 2.4 kg (IDeg); 2.1 kg (IGlar). Adverse event rates were low and similar between groups. In this treat-to-target trial, IDeg and IGlar provided similar long-term glycemic control, with significantly lower rates of nocturnal hypoglycemia with IDeg.