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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
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.
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).
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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