The results for insulin degludec along with those of a trial that combines insulin degludec with insulin aspart, dubbed DegludecPlus, and the first phase III trial of liraglutide for obesity treatment were released.
Similar to results of a proof-of-concept study presented at the American Diabetes Association meeting in June, the novel ultra-long-acting insulin degludec reduced hemoglobin A1c by virtually the same degree as insulin glargine (Lantus).
The 26-week phase IIIa trial in Type 2 diabetes patients previously treated with oral anti-diabetic therapy or basal insulin or both randomized participants to the following on top of existing oral therapy:
- Insulin degludec in a flexible dosing regimen with eight-to-40-hour intervals between doses
- Insulin degludec given in the evening
- Insulin glargine given as labeled
The trial met its primary objective with flexible insulin degludec dosing, showing noninferiority compared with insulin glargine as both arms dropped hemoglobin A1c by 1.3 percentage points, to around 7.2% in both groups.
Dosing that allowed patients to go days without a shot using the flexible insulin degludec schedule wasn't any less effective for glucose control than once-daily dosing. Both groups that got the ultra-long-acting insulin tended to see fewer nighttime hypoglycemia episodes compared with insulin glargine.
The company reported good safety and tolerability of the novel agent without any apparent differences in adverse event rates and safety parameters.
Novo Nordisk also reported the results of the second phase IIIa study with the novel combination insulin DegludecPlus, premixed insulin degludec and insulin aspart. The study included patients with "late-stage" Type 2 diabetes randomized to receive either DegludecPlus or biphasic insulin aspart (NovoMix 30) twice daily added to their standard oral anti-diabetic therapy.
Results with the insulin degludec combination included:
- Noninferiority for the primary endpoint of hemoglobin A1c reduction (1.5 percentage points to 7.1% in both groups).
- Lower fasting and mean plasma glucose levels compared with biphasic insulin aspart
- Lower total daily insulin dose at study completion compared with biphasic insulin aspart
- More than two-thirds fewer nocturnal hypoglycemia episodes and significantly fewer confirmed hypoglycemia episodes overall compared with biphasic insulin aspart
- Slightly less weight gain with DegludecPlus
- No difference in safety or tolerability
Reported by Novo Nordisk Oct. 2010