Discovery

Once-weekly insulin shot could simplify the future of diabetes treatment

Clinical trials have shown a once-weekly insulin injection to be as safe and effective for patients with Type 2 diabetes as daily injections.

A huge step forward in making Type 2 diabetes management easier is on the horizon: the promise of a once-weekly insulin injection.

Three international clinical trials have shown that a new insulin injection taken just once a week could be as safe and effective as daily insulin injections. Several more trials involving thousands of people are currently underway at multiple sites, including UT Southwestern.

Approximately 10% of people in the U.S. have Type 2 diabetes, in which the body cannot use insulin properly and needs to produce more insulin to keep up with the demand. When the body can no longer keep up with the increased demand in insulin production, blood sugar levels rise.

Well over 90% of all diabetes cases worldwide are Type 2, and approximately 374 million people have impaired glucose tolerance (pre-diabetes) – a number expected to grow to 548 million by 2045.

Related reading: Protecting teens and young adults from Type 2 diabetes

Currently, patients who are prescribed insulin must take daily self-injections to regulate their blood sugar. Such a regimen can be cumbersome, inconvenient, and difficult to remember, becoming a barrier to starting insulin or maintaining a steady regimen, and ultimately leading to suboptimal diabetes treatment. If not well-controlled, Type 2 diabetes can cause serious conditions such as heart and kidney disease and blindness.

Factors such as genetics, aging, and obesity are contributing to increasing rates of Type 2 diabetes, so we must develop new treatment options and novel approaches to diabetes management to benefit all our patients with diabetes.

I recently published two studies on once-weekly insulin injections in Diabetes Care – one, as lead author, that included 205 patients with Type 2 diabetes from seven countries and one, as co-author, that studied 154 patients with Type 2 diabetes from five countries.

Our major finding was that the once-weekly insulin is just as effective and safe as the daily insulin product we have been using for years. In both studies, we evaluated the best ways to use this new treatment to ensure we know how to prescribe it and adjust doses over time.

I’m excited to discuss the potential significance of this finding, which includes:

  • The decrease in treatment burden for our patients, which can lead to better adherence and diabetes control
  • Improved confidence for caregivers and providers

From trials to available treatment: A timeline

The insulin injection we studied, icodec, binds to albumin, a protein abundantly circulating in the blood. Slowly and evenly, icodec is designed to provide steady insulin action over seven days.

Both phase-two clinical trials included two weeks of screening, 16 weeks of treatment, and five weeks of follow-up to allow us to thoroughly evaluate and optimize insulin doses in each patient. Participants were ages 18-75. We recorded their glucose levels every five minutes using monitoring devices they were required to wear at all times.

Trial results so far suggest that the once-weekly injection compares well with the daily insulin counterpart. There was equal reduction in glucose level and no increase in the rate of low blood sugar between those receiving once-weekly icodec and those receiving the daily insulin glargine.

We’re now about halfway through the phase-three trials, which are designed to confirm whether icodec is safe and effective for a variety of patients with Type 2 diabetes, as well as those with Type 1 diabetes. About 40 people are being evaluated in these studies at UT Southwestern, and several thousand are enrolled in these trials around the world.

When the phase-three trial results are validated, the next step is to submit the data to the U.S. Food and Drug Administration (FDA) for review and approval. If all goes according to schedule, once-weekly insulin injection could become available to patients in 2024.

Potential benefits for patients

Better adherence, improved quality of life

Previous research has shown that up to 40% of patients with Type 2 diabetes decline insulin treatment, resulting in poor blood sugar control. Often, patients cite quality of life issues as to why they hesitate to use insulin:

  • Fear of needles
  • Embarrassment due to stigmas around the disease
  • Inconvenience
  • Worry about fluctuating blood sugar levels

Patients want to avoid the physical and emotional burdens of injecting insulin – especially because many take several medications for other conditions, such as high blood pressure and high cholesterol.

With a once-weekly shot, patients with Type 2 diabetes could spend less time managing their disease while still benefiting from insulin treatment.

Improved caregiver and provider confidence

Accurate insulin dosage is critical to the safety and well-being of patients with diabetes. Taking too much can result in hypoglycemia (low blood sugar) and cause dizziness, fatigue, shaking, heart palpitations, seizures, or unconsciousness. Taking too little would lead to high glucose levels.

A once-weekly injection could decrease concerns regarding the accuracy of the dosage on a day-to-day basis. Fluctuating daily routines can lead to variation in dosing time of the daily insulin, which can cause low or high sugar levels. A once-weekly treatment would not be affected by such variations and would instead provide a steadier day-to-day insulin level.

This new treatment could also benefit patients who need help getting injections, such as those who have memory problems or live in long-term care facilities. A once-weekly administration would decrease the burden not only on the patient but also on the care provider.

As we continue to discover new ways to simplify diabetes treatment, the future of diabetes care looks more manageable – for both patients and providers – than ever before.

For a diabetes treatment plan customized to your symptoms and lifestyle, call 214-645-8300 or request an appointment online.