Po343 Treatment Intensification With Idegasp Bid vs Ideg Od Plus Iasp in Insulin-Treated Patients With Type 2 Diabetes: A Randomized, Controlled Phase 3 Trial

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

“…Although HbA 1c was reduced in both trial arms (to 7.0% and 6.8%, respectively) and the proportion of patients achieving the HbA 1c target of <7% was similar between both groups (56.5% vs. 59.6%, respectively) [50], the daily total dose at the end of the trial was 1.11 U/kg with IDegAsp versus 1.34 U/kg with IDeg once daily plus mealtime IAsp. IDegAsp was not shown to be non-inferior to IDeg + IAsp (upper CI bound +0.41%-units).…”

“…However, people on IDegAsp gained significantly less weight, perhaps associated with the lower mean total daily insulin dose, the treatment difference being large for a 26-week trial (estimated treatment difference [ETD]: −1.0 [95% CI −2.0, −0.1] kg, p < 0.05) [49]. Comparison of overall changes from baseline score for social functioning using a health-related quality of life questionnaire (SF-36 v2) showed that IDegAsp was associated with better social functioning than IDeg once daily plus mealtime IAsp (ETD 2.2 [95% CI 0.3, 4.1]; p < 0.05) [50].…”

“…Caution is needed in the interpretation of this trial because, as a result of an unfamiliar insulin or a smaller number of injections per day in the IDegAsp arm, the daily insulin dose was lower [48,49], which might account for the marginal failure (0.41 vs. a criterion of 0.40%-units) to reach non-inferiority for the primary end point of change in HbA 1c after 26 weeks [50]. However, there were fewer confirmed and nocturnal hypoglycemia episodes, suggesting that IDegAsp is a reasonable clinical choice in this circumstance for a reduced number of injections, although a further trial is warranted, particularly a longer trial as islet β-cell function declines.…”