A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive XXXX with type 2 @entity6 : a randomized, controlled trial.

@entity1 @entity3916 @entity6 @entity4373 @entity4053 @entity2574 @entity413 @entity2449
OBJECTIVE: Insulin degludec/insulin aspart (IDeg @entity2574 ) is a soluble coformulation of the novel basal analog insulin degludec (IDeg: 70%) and insulin aspart (IAsp: 30%). We compared the safety and efficacy of IDegAsp, an @entity4373 ( @entity4373 ) (55% IDeg and 45% IAsp), and insulin glargine (IGlar) in insulin-na  ve subjects with type 2 @entity6 inadequately controlled with oral antidiabetic drugs. RESEARCH DESIGN AND METHODS: In this 16-week, open-label trial, subjects (mean age 59.1 years, @entity3916 8.5%, BMI 30.3 kg/m(2)) were randomized to once-daily IDegAsp (n = 59), @entity4373 (n = 59), or IGlar (n = 60), all in combination with @entity2449 . Insulin was administered before the evening meal and dose-titrated to a fasting plasma @entity413 (FPG) target of 4.0-6.0 mmol/L. RESULTS: After 16 weeks, mean @entity3916 decreased in all groups to comparable levels (IDegAsp: 7.0%; @entity4373 : 7.2%; IGlar: 7.1%). A similar proportion of subjects achieved @entity3916 <7.0% without confirmed @entity4053 in the last 4 weeks of treatment (IDegAsp: 51%; @entity4373 : 47%; IGlar: 50%). Mean 2-h postdinner plasma @entity413 increase was lower for IDeg @entity2574 (0.13 mmol/L) and @entity4373 (0.24 mmol/L) than IGlar (1.63 mmol/L), whereas mean FPG was similar (IDegAsp: 6.8 mmol/L; @entity4373 : 7.4 mmol/L; IGlar: 7.0 mmol/L). @entity4053 rates were lower for IDegAsp and IGlar than @entity4373 (1.2, 0.7, and 2.4 events/ @entity1 year). Nocturnal hypoglycemic events occurred rarely for IDeg @entity2574 (1 event) and IGlar (3 events) compared with @entity4373 (27 events). CONCLUSIONS: In this proof-of-concept trial, once-daily IDegAsp was safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of @entity4053 , but better postdinner plasma @entity413 control.
