MedWire News: A new insulin coformulation, known as IDegAsp, has shown initial promise in a proof-of-concept trial when given once daily in combination with metformin to patients with Type 2 diabetes.
The new drug is a soluble mix of two different insulin analogs: the new-generation ultra-long-acting insulin degludec (IDeg; 70%) as the basal insulin, together with insulin aspart (IAsp; 30%) as prandial insulin.
"By providing both basal and rapid-acting insulin analogs in one injection, IDegAsp could be an attractive alternative to the common strategy of initiating insulin therapy with basal insulin only on top of oral antidiabetic drugs," explain Tim Heise (Profil Institut für Stoffwechselforschung, Neuss, Germany) and fellow investigators in the journal Diabetes Care.
Heise et al conducted a 16-week, open-label, randomized controlled trial involving 178 insulin-naïve patients who were inadequately controlled on oral antidiabetic drugs. The patients' mean age was 59.1 years and mean HbA1c at baseline was 8.5%.
They were randomly assigned to one of three treatments, all in combination with metformin: once-daily IDegAsp; an alternative formulation comprising 55% IDeg and 45% IAsp (AF); or insulin glargine (IGlar). Insulin was given before the evening meal and dose-titrated to achieve a fasting plasma glucose (FPG) target of 4.0-6.0 mmol/l.
By the end of treatment, HbA1c had fallen by 1.3%, 1.5%, and 1.3% in the IDegAsp, AF, and IGlar groups, respectively, indicating no significant difference among the three treatments.
The proportion of patients who had achieved the HbA1c target of 7.0% or less was 52%, 56%, and 51% in the IDegAsp, AF, and IGlar groups, respectively, while the proportion achieving a target of 6.5% or less was 33%, 37%, and 24%, respectively.
The mean 2-hour post-dinner rise in plasma glucose was less with IDegAsp and AF than with IGlar (0.13 and 0.24 vs 1.63 mmol/l), whereas the mean FPG was similar with the three treatments (6.8, 7.4, and 7.0 mmol/l).
Finally, hypoglycemia rates were lower for IDegAsp and IGlar than AF, at 1.2 and 0.7 versus 2.4 events/patient year, respectively.
The investigators conclude that once-daily IDegAsp appears "safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of hypoglycemia, but better post-dinner plasma glucose control."
The IDegAsp coformulation is now being studied in phase III trials.
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