Once-a-week injectable insulin therapy found to be safe and as effective as daily insulin injections, according to the results of international clinical trials published online in Diabetes Care.
Initiating and maintaining insulin treatment remain a problem for many patients worldwide with Type 2 diabetes. Fear of injections and the inconvenience and burden of injectable therapy contribute to the barriers against insulin therapy initiation and adherence.
Reducing the frequency of treatment administration with advances, such as the once-weekly insulin used in these phase 2 trials, may decrease the reluctance to initiate insulin therapy while improving long-term adherence, glucose control, and ultimately, patient well-being.
"Insulin treatment is burdensome, requires frequent injections, and continues to carry a certain stigma. The development of an effective and safe insulin that can be administered once a week is a huge advance in the field."
With two-week screening period, 16 weeks of treatment, and a five-week follow-up, the trial evaluated three different ways to adjust and optimize the insulin dose and to assess which one presented the best balance between effectively lowering glucose while minimizing low-glucose events.
Second study included 154 patients from five countries (the U.S., Canada, the Czech Republic, Germany, and Italy).
During the 23-week time frame, the second trial evaluated practical aspects of insulin use as well as the best ways to transition from a daily regimen to the new weekly insulin injections. The researchers determined that starting with a higher first dose - called a loading dose - allowed patients to reach their optimal glucose target faster.
"These two studies served as the steppingstones for a large phase 3 clinical trial program that is currently ongoing at UT Southwestern and other sites, which is designed to evaluate the efficacy of once-weekly insulin administration in patients with either Type 1 or Type 2 diabetes," Lingvay says.
"A weekly insulin is a game-changer that will decrease the treatment burden for patients while also improving compliance. This treatment will also decrease the burden on those who care for patients with diabetes requiring insulin.
For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers."