Oral Presentation The Joint Annual Scientific Meetings of the Endocrine Society of Australia and the Society for Reproductive Biology 2017

SWITCH 1: Reduced risk of hypoglycaemia with insulin degludec vs. insulin glargine U100 in patients with type 1 diabetes – a randomised, double-blind, crossover trial (#45)

Wendy Lane 1 , Timothy S Bailey 2 , Gregg Gerety 3 , Janusz Gumprecht 4 , Athena Philis-Tsimikas 5 , Charlotte T Hansen 6 , Thor Schütt Svane Nielsen 6 , Mark L Warren 7 , Gregory R Fulcher 8
  1. Mountain Diabetes and Endocrine Center, Asheville, NC, USA
  2. AMCR Institute, Escondido, CA, USA
  3. Albany Medical Center, Albany, NY, USA
  4. Medical University of Silesia, Zabrze, Poland
  5. Scripps Health Whittier Diabetes Institute, San Diego, CA, USA
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Physicians East, Greenville, NC, USA
  8. University of Sydney, Royal North Shore Hospital, St Leonards, NSW, Australia

A 64-week, double-blind, treat-to-target crossover trial randomised 501 adults with type 1 diabetes (T1D) and ≥ one factor associated with increased risk of developing hypoglycaemia to once-daily insulin degludec (IDeg) or insulin glargine U100 (IGlar U100), both with mealtime insulin aspart for 32 weeks (16-week titration period, 16-week maintenance period), followed by crossover to IGlar U100 or IDeg.

The primary objective was to confirm non-inferiority in the number of severe (requiring third-party aid, all externally adjudicated) or blood glucose (BG)-confirmed (<3.1 mmol/L) symptomatic hypoglycaemic episodes during the maintenance periods. Treatment with IDeg vs. IGlar U100 resulted in significantly lower rates of severe or BG-confirmed symptomatic hypoglycaemia, severe or BG-confirmed symptomatic nocturnal hypoglycaemia (occurring between 00:01 am and 05:59 am), and severe hypoglycaemia for maintenance and total treatment periods (Fig).

IDeg was superior to IGlar U100 regarding a lower proportion of patients experiencing severe hypoglycaemia during maintenance and total treatment periods. HbA1c non-inferiority of IDeg vs. IGlar U100 was confirmed in both treatment periods (means, week 32: 6.95 vs. 6.92%; week 64: 6.95 vs. 6.97%). Adverse event rates were similar for IDeg vs. IGlar U100. In this T1D population, IDeg significantly reduced the rates and proportions of severe hypoglycaemia and the rates of BG-confirmed symptomatic overall and nocturnal hypoglycaemia vs. IGlar U100.