medwireNews: A novel insulin that can be given as a once-weekly injection has achieved promising results in a randomized phase 2 trial involving people with type 2 diabetes.
The study participants were insulin naïve, with an average glycated hemoglobin (HbA1c) level of 8.0%, despite all using metformin and 46.6% also using a dipeptidyl peptidase 4 inhibitor. They were an average age of 59.6 years with an average diabetes duration of 9.7 years and BMI of 31.3 kg/m2.
The study medication was insulin icodec, which has been modified to achieve a half-life of approximately 1 week. The 121 people who received this as a weekly injection for 26 weeks also took a daily placebo injection, whereas the 115 who were randomly assigned to take daily insulin glargine U100 received a weekly placebo injection.
The primary endpoint was HbA1c at week 26, and this was 6.7% (50 mmol/mol) and 6.9% (52 mmol/mol) in people taking incodec and glargine, respectively. The estimated mean reductions from baseline to week 26 were 1.33% and 1.15%, with no significant difference between the two.
There were also no significant differences between the two in the proportion of people achieving HbA1c targets or in fasting plasma glucose levels over time. However, incodec use appeared to result in significantly lower blood glucose 90 minutes after breakfast and after lunch.
In addition, the total amount of insulin used over the course of a week during the last 2 weeks of the study was significantly lower with incodec than glargine, at 229 versus 284 U/week. Julio Rosenstock (University of Texas Southwestern Medical Center, Dallas, USA), who presented the findings at the virtual ADA 80th Scientific Sessions, noted these amounts are equivalent to approximately 33 versus 41 U/day.
He commented that advances in basal insulin analogs have significantly changed the management of insulin-dependent type 2 diabetes.
“If the results of this study are confirmed in the subsequent phase 3 study, I believe, personally, that a weekly basal insulin has the potential to be transformational in the management of type 2 diabetes needing insulin therapy,” he said.
There were no differences in bodyweight changes between the two treatment groups, nor in hypoglycemia outcomes, including nocturnal hypoglycemia.
Adverse events were generally similar between the groups, bar a high number of serious events in the glargine group almost all attributed to one person with underlying chronic kidney disease, and a high number of injection site reactions in the incodec group, with the majority again occurring in just one participant.
Two other presentations in the same session detailed the molecular, biologic, and pharmacodynamic/pharmacokinetic properties of this new long-acting insulin.
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