Oral Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2017

SWITCH 2: reduced hypoglycaemia with insulin degludec vs. insulin glargine, both U100, in patients with type 2 diabetes at high risk of hypoglycaemia – a randomised, double-blind, crossover trial (#106)

Carol H Wysham 1 , Anuj Bhargava 2 , Louis B Chaykin 3 , Raymond de la Rosa 4 , Yehuda Handelsman 5 , Lone Nørgård Troelsen 6 , Kajsa Kvist 6 , Paul Norwood 7 , Gregory Fulcher 8
  1. Rockwood Clinic, Spokane, Washington, USA
  2. Iowa Diabetes and Endocrinology Research Center, Des Moines, Iowa, USA
  3. Meridien Research, Bradenton, Florida, USA
  4. Paducah Endocrinology, Paducah, Kentucky, USA
  5. Metabolic Institute of America, Tarzana, California, USA
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Valley Research, Fresno, California, USA
  8. Royal North Shore Hospital, The University of Sydney, St Leonards, New South Wales, Australia

In this 2x 32-week, double-blind, treat-to-target crossover trial, adults (n=721) with type 2 diabetes (T2D) were randomised 1:1 to receive once-daily insulin degludec (IDeg)/insulin glargine (IGlar) U100, followed by crossover to IGlar/IDeg. Each treatment period comprised a 16-week titration and 16-week maintenance period. Patients included were previously treated with basal insulin ± oral antidiabetic drugs excluding sulphonylureas/meglitinides, and at increased risk of developing hypoglycaemia based on pre-trial risk factors. The primary endpoint was the number of severe (requiring third-party assistance and external adjudication) or blood glucose-confirmed (<3.1 mmol/L) symptomatic hypoglycaemic events in the maintenance periods.

Treatment with IDeg resulted in significantly lower rates of severe or confirmed symptomatic hypoglycaemia and severe or confirmed symptomatic nocturnal hypoglycaemia (occurring 00:01–05:59) versus IGlar (Figure). The proportion of patients experiencing severe hypoglycaemia in the maintenance periods was 1.6% for IDeg versus 2.4% for IGlar (p=not significant). Severe hypoglycaemia rates were significantly lower with IDeg versus IGlar in the total treatment period. HbA1c reductions with IDeg were non-inferior to IGlar. Adverse event rates were similar.

Compared with IGlar, IDeg resulted in a consistent reduction in hypoglycaemia in T2D patients at high risk of hypoglycaemia.

Figure. Rate ratios of hypoglycaemia in patients with type 2 diabetes at high risk of hypoglycaemia.

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