Eli Lilly has announced positive phase 3 results for its once-weekly insulin, efsitora alfa (efsitora). This news represents a significant advancement in diabetes management, potentially transforming treatment for millions of people living with type 2 diabetes.

Phase 3 Clinical Trials: QWINT-2 and QWINT-4

Eli Lilly’s phase 3 trials, QWINT-2 and QWINT-4 evaluated the efficacy and safety of efsitora. The QWINT-2 trial compared efsitora to Novo Nordisk’s daily insulin degludec (Tresiba) over 52 weeks in insulin-naïve adults. The trial successfully met its primary endpoint, demonstrating that efsitora was non-inferior (at least as good as) to degludec in reducing HbA1c levels. Efsitora reduced HbA1c by 1.34%, while degludec achieved a 1.26% reduction, resulting in final HbA1c levels of 6.87% and 6.95%, respectively.

The QWINT-4 trial compared efsitora to insulin glargine (Lantus) over 26 weeks in adults previously treated with basal insulin and mealtime insulin. Both treatments reduced HbA1c by 1.07%, demonstrating comparable efficacy. Importantly, efsitora was well-tolerated in both trials, though it did show slightly higher rates of hypoglycemic events compared to the daily insulins. Hypoglycemia is always a possibility for anyone taking insulin.

The Competitive Landscape: Novo Nordisk's Insulin Icodec

Eli Lilly's success with efsitora comes amid fierce competition with Novo Nordisk, another principal producer of insulin. Novo Nordisk's once-weekly insulin, Icodec (Awiqli®), is currently under FDA review, with approval anticipated later this year. Icodec has already demonstrated promising results, achieving superior blood sugar reduction and increased Time in Range compared to daily basal insulins in clinical trials.

Comparing Efsitora Alfa and Icodec

Both efsitora and Icodec aim to reduce the burden of daily injections for people with diabetes, offering a once-weekly alternative. Key comparisons include:

• Efficacy: Both insulins have shown non-inferior HbA1c reduction compared to daily basal insulins. Efsitora demonstrated a reduction of 1.34% in the QWINT-2 trial, while Icodec's trials showed superior blood sugar control and Time in Range.
• Safety: Efsitora has slightly higher rates of hypoglycemic events compared to degludec and glargine. Icodec, while generally safe, also showed increased hypoglycemia risk in certain trials.
• Adherence: The once-weekly dosing schedule of both insulins promises to improve adherence and overall quality of life for patients.

The Future of Diabetes Treatment

Once-weekly insulins like efsitora and Icodec mark a noteworthy advancement in diabetes treatment. These innovations will significantly reduce the daily burden of managing diabetes, potentially improving treatment adherence and health outcomes. As both Eli Lilly and Novo Nordisk continue to innovate in diabetes care, patients can look forward to more convenient and effective treatment options.

With regulatory approvals coming, the future of diabetes management looks brighter than ever.

Frequently Asked Questions

How soon can patients expect to see improvements in their blood sugar levels after starting efsitora alfa?
Patients may begin to see improvements in blood sugar levels within the first few weeks of starting efsitora alfa, as it gradually stabilizes glucose levels over time.

Are there any dietary or lifestyle changes recommended when switching to once-weekly insulin?
No specific dietary or lifestyle changes are required when switching to once-weekly insulin, but maintaining a healthy diet and regular exercise routine is always beneficial for diabetes management.

How do once-weekly insulins affect insulin sensitivity compared to daily insulins?
Once-weekly insulins like efsitora alfa are designed to provide stable insulin levels throughout the week, which may help maintain insulin sensitivity similarly to daily insulins.

How do patients and caregivers feel about switching to once-weekly insulin?
Feedback from patients and caregivers has been positive, highlighting the convenience and reduced injection burden as significant benefits of once-weekly insulin.

How will once-weekly insulins be integrated into existing diabetes treatment guidelines?
Once-weekly insulins are expected to be incorporated into diabetes treatment guidelines as an alternative to daily basal insulins, especially for patients who struggle with adherence to daily injections.