FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Xultophy Demonstrates Similar Glucose Control Compared to Basal-Bolus Therapy

Dec. 12, 2016

Novo Nordisk released Phase IIIb trial results that demonstrate Xultophy’s non-inferiority to insulin glargine U100 in combination with insulin aspart.

After six months of treatment, patients taking Xultophy reported lower rates of symptomatic hypoglycemic episodes, compared to the insulin combination. The open-label trial compared Xultophy to the insulin combination, given at all main meals, in 506 adults with Type 2 diabetes.

Xultophy, a fixed-dose combination of long-acting basal insulin and a receptor agonist that helps the pancreas secrete insulin in response to high blood sugar, was recently approved by the FDA.

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