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Switch 1 Trial: Degludec versus Glargine in Type I Diabetes

Conference Lecture with Wendy S. Lane / ADA 76th Scientific Sessions, New Orleans, June ‘16

Elsevier Digital Insulin Educational Programme: Extra Lane

Wendy S. Lane, MD, Mountain Diabetes and Endocrine Centre, Ashville, North Carolina, presented results from the SWITCH 1 trial at the 76th scientific session of the American Diabetes Association 2016 in New Orleans, US, June 10-14.  

Design of SWITCH 1

The SWITCH 1 trial was designed to evaluate the risk of hypoglycemia in patients with type I diabetes using insulin degludec (IDeg), a new long-acting basal insulin, or insulin glargine (IGlar). The trial included patients at high risk for hypoglycemia, long-term use of insulin, a 23 year average history of type I diabetes or hypoglycemic unawareness.

The overall objective was to determine if a switch from IGlar to IDeg has a benefit or if there is no difference of hypoglycemic risk between standard treatment and IDeg. 501 patients were recruited, double blinded and randomized to either IDeg or IGlar. After a 32-week treatment period the patients were crossed over to the other insulin product. The 32-week period consisted of a 16-week titration phase followed by a 16-week maintenance phase.

Clinical endpoints

The primary endpoint of the study was the incidence of severe (defined as requirement of assistance for treatment) or confirmed symptomatic hypoglycemia (defined as blood glucose of <56mg/dL confirmed by finger stick).

Results

IDeg reduced the primary endpoint of severe or blood glucose confirmed symptomatic hypoglycemia  by a statistically significant 11% compared to IGlar. More importantly IDeg lowered the rate of severe nocturnal hypoglycemia: IDeg had a 36% lower incidence of severe nocturnal hypoglycemia compared to IGlar. The rate of severe hypoglycemia over the maintenance period was 35% less for IDeg versus IGlar. Both study groups showed a reduction of HBA1c from a mean baseline of 7.6% but the treatment arm with IDeg achieved additionally a reduction in hypoglycemia. This is a progress in the treatment of patients with type I diabetes.

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