A once-weekly basal insulin injection for type 2 diabetes took a huge step towards approval after good results were achieved in a critical Phase 2 study that showed it was just as safe and effective as daily insulin injections.
Those who prefer one thrust to seven should hear the news.
In a study of 399 patients with type 2 diabetes, once-weekly insulin injections lowered HbA1c, as did a more aggressive regimen of traditional daily insulin injections. The weekly insulin also resulted in significantly less hypoglycemia. Overall, the study was a remarkable success for the new drug.
Dr. Juan Frias, the lead researcher, stated that new weekly insulin injections “have the potential to be flatter and more predictable than current daily basal insulins, which may have contributed to lower hypoglycemia rates.”
The results of the study have not yet been published but were highlighted in a press release ahead of a presentation at ENDO 2021, the annual meeting of the Endocrine Society.
At the time, the lead investigator of the Novo Nordisk study predicted that weekly insulin injections would be “transformative”. The appeal of a single injection versus seven daily should be evident. One can expect that a weekly injection will prove very popular and can even improve patient adherence. Many people with type 2 diabetes have difficulty using insulin because it has been prescribed for a variety of reasons, including discomfort with needles.
Eli Lilly also announced that it is accelerating the investigation of weekly insulin injections in patients with type 1 diabetes. However, this will likely prove to be a tougher challenge. Type 1 blood sugar tends to be more volatile, and a decreased ability to respond to short-term changes in insulin needs (whether due to exercise, illness, alcohol consumption, or other unpredictable factors) can be problematic for patients. The success of the insulin pump over the years shows that many with Type 1 prefer more ways to fine-tune their insulin usage, not less.
Interestingly, participants in the new study who were given weekly insulin aimed for higher fasting blood sugar levels (120-140 mg / dL) than those who were assigned daily insulin injections (100 mg / dL). And yet, after starting on equivalent A1c, they showed essentially the same improvement in blood sugar levels. This mimics an encouraging finding from the previous Novo Nordisk study, which showed that participants who were assigned weekly insulin used significantly less insulin to get the same blood sugar improvements as daily insulin. Our housewife Dr. Mariela Glandt has argued that insulin use is problematic in type 2 diabetes.
Next up is Eli Lilly’s weekly insulin: a phase 3 study, generally the last major hurdle to overcome in the road to government approval. Phase 3 studies are usually larger and longer than phase 2 studies and allow researchers to better assess the safety of the drug by identifying side effects and other unintended outcomes.
