A once-weekly basal insulin injection for Type 2 diabetes took a big step towards approval after posting good results in a Phase 2 critical trial, showing that it was just as safe and effective as daily insulin injections.
Those that prefer one jab to seven jabs should applaud the news.
In a study of 399 patients with Type 2 diabetes, once-weekly insulin injections lowered HbA1c just as much as a more aggressive regimen of traditional daily insulin injections. The weekly insulin also resulted in significantly less hypoglycemia. All told, the trial was a notable success for the new drug.
Dr. Juan Frias, the principal investigator, explained that new weekly insulin injections have “the potential of a flatter and more predictable action than the current daily basal insulins, which may have contributed to the lower rates of hypoglycemia.”
The study’s results have not yet been published, but were highlighted in a press release in advance of a presentation at ENDO 2021, the Endocrine Society’s annual meeting.
The new insulin is being developed by pharmaceutical giant Eli Lilly. Lilly is several months behind its competitor Novo Nordisk, which announced the completion of its own Phase 2 trial last summer.
At the time, the lead investigator of the Novo Nordisk trial predicted that weekly insulin injections would be “transformational.” The appeal of one single injection, as compared to seven daily ones, should be obvious. It seems safe to assume that a weekly injection will prove to be very popular, and may even improve patient adherence. Many people with Type 2 diabetes struggle to use insulin as it’s been prescribed for a variety of reasons, including discomfort with needles.
Eli Lilly also announced that it was accelerating its investigation of weekly insulin injections for patients with Type 1 diabetes. That, however, will likely prove a more difficult challenge. The blood sugar of people with Type 1 tends to be more volatile, and a reduced ability to respond to short-term changes in insulin needs (whether due to exercise, illness, alcohol use or other unpredictable factors) may be problematic for patients. The success of the insulin pump over the years shows that many with Type 1 prefer more opportunities for fine-tuning their insulin usage, not fewer.
Interestingly, participants of the new study that had been assigned weekly insulin targeted a higher fasting blood glucose level (?120-140 mg/dL) compared to those assigned daily insulin injections (?100 mg/dL). And yet, having begun with equivalent A1c’s, they enjoyed essentially the same improvement in blood sugar levels. This mimics an encouraging result from the earlier Novo Nordisk trial, which showed that participants assigned weekly insulin used significantly less insulin in order to achieve the same blood sugar improvements as those on daily insulin. Our house expert Dr. Mariela Glandt has argued the use of insulin for Type 2 diabetes is problematic.
Next up for Eli Lilly’s weekly insulin: a Phase 3 trial, generally the last major hurdle to clear in the path towards government approval. Phase 3 studies are typically larger and longer than phase 2, and allow investigators to better assess the drug’s safety by teasing out side effects and other unintended results.