Weekly insulin found safe, effective for Type 2 diabetes

July 14, 2023
Phase 3 clinical trial led by UTSW researcher brings icodec injections one step closer to FDA approval.

An experimental form of insulin administered just once a week was safe for patients with Type 2 diabetes and helped them maintain healthy blood sugar levels better than insulin injected daily, according to the results of a phase 3 clinical trial led by a UT Southwestern Medical Center researcher. The findings are published in JAMA.

The study used a rigorous double-blind randomized control trial. Specifically, the patients were randomized to one of two therapies: injected icodec once a week and a placebo daily, or injected degludec daily and a placebo once a week. The primary endpoint of the study was a change in a blood measure of longitudinal glucose control, namely hemoglobin A1C (HbA1C).

After 26 weeks of treatment and five weeks of follow-up, patients on weekly icodec had significantly larger improvements in their HbA1C than those using degludec daily.

Both groups had an extremely low rate of adverse events, said endocrinologist Ildiko Lingvay, M.D., M.P.H., M.S.C.S., Professor of Internal Medicine at UT Southwestern and its Peter O’Donnell Jr. School of Public Health. This suggests that both forms of insulin are safe. Although the patients who received icodec had a slightly higher risk of low-blood sugar events, none of the events were severe enough to require emergency medical attention.

Dr. Lingvay participated in three other phase 3 trials testing icodec at UTSW and other sites. In ONWARDS 1 and ONWARDS 5, patients on icodec stayed in a healthy blood sugar range noticeably more often than patients on degludec. In ONWARDS 4, people treated with weekly insulin had similar improvement in glucose and similar occurrence of hypoglycemia compared with those on once-daily insulin.

UT Southwestern Medical Center release on Newswise