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Switch 2 Trial: Reduced Hypoglycemia with Insulin Degludec

Conference Lecture with Carol H. Wysham / ADA 76th Scientific Sessions, New Orleans, June ‘16

Elsevier Digital Insulin Educational Programme: Extra Wysham

Carol H. Wysham, Clinical Associate Professor University of Washington, Spokane, WA, outlines the SWITCH 2 trial which was presented at the 76th scientific session of the American Diabetes Association 2016 in New Orleans, US, June 10-14.  

Study design

SWITCH 2 is a trial in patients with type II diabetes to evaluate the relative risk of hypoglycemia between degludec insulin (IDeg) and glargine insulin (IGlar). The patients selected had been on basal  insulin for at least 6 months and weren’t able to receive good glycemic control. The patients were randomized between IDeg and IGlar. They underwent a 16 week titration phase followed by a 16 week maintenance period. At the end the patients were crossed over to the opposite insulin with an identical titration and maintenance period.

Clinical endpoints

The primary objective was to prove superiority of IDeg over IGlar as related to the combination of severe hypoglycemia and blood sugar (BG) confirmed symptomatic hypoglycemia. They also evaluated secondary endpoints including severe hypoglycemia and nocturnal hypoglycemia. Finally the rates of severe hypoglycemia between the two groups were evaluated.

Results

The HBA1c were identical for both insulins. For the primary endpoint a 30% reduction in the rates of severe or BG-confirmed hypoglycemia with IDeg versus IGlar was shown. Additionally a 42% reduction in the risk of severe and nocturnal confirmed symptomatic hypoglycemia was observed for IDeg versus IGlar.

Conclusion

IDeg was to be found to be superior to IGlar in terms of reducing the risk of severe and overall symptomatic BG-confirmed hypoglycemia. The effects are of clinical importance because hypoglycemia is the primary impediment to achieve good glycemic control in patients with longstanding type II diabetes. The achievement of a good glycemic control with less hypoglycemia might allow to titrate the patients more aggressively to lower target fasting glucose levels. A better HBA1c control will help the patients to stay safe.

 

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