The new pill form of semaglutide is considered to be promising and effective in controlling blood sugar levels in patients with type 2 diabetes. The scientists have finished a 26-week phase II clinical study and revealed that semaglutide showed statistically significant better glycemic control than a placebo. The paper was published in The Journal of the American Medical Association (JAMA) with the first author Dr. Melanie Davies of the Diabetes Research Centre at the University of Leicester in the United Kingdom. The obtained results provide a rationale for conducting phase III studies to evaluate the longer-term effects and safety of semaglutide in pill version.
It’s estimated that more than 90 percent of the 30 million people with diabetes in the US suffer from type 2 diabetes. To choose the best treatment option, doctors need to consider the complexity of the therapy and the possible risk of side effects, such as hypoglycemia or putting on weight. The authors believe that a pill form of semaglutide may be more suitable for some patients and therefore improve patient compliance and decrease the risk of complications.
For the phase II trial mentioned above, Dr. Davies and her colleagues included 632 patients with type 2 diabetes whose present therapy was not effective in terms of achieving adequate glycemic control. Thus, these patients had to take some actions in order to lower blood sugar, for example, do physical exercises or add-on metformin. The patients were randomized to different groups. Some groups were prescribed a daily pill form of semaglutide or a placebo, while others received a weekly injection of semaglutide. However, those patients who took the oral version of semaglutide were in groups that received different fixed daily doses or progressively increasing daily doses. Patients took medicines or placebo for 26 weeks. Glycosylated hemoglobin (HbA1c) level was the main outcome measure.
The researchers have demonstrated that the average alteration in HbA1c level over the 26 weeks of the trial fell in all the groups, with the major decrease in the patients who received semaglutide injections (1,9%). Though, all dosages of the oral version of semaglutide decreased average HbA1c (from -0,7 percent to -1,9%) significantly more than placebo (-0,3%) by the end of the trial. The authors have also found out that between 44–90% of patients who received the pill form of semaglutide (depending on dosage) achieved the target level of glycosylated hemoglobin (7%). What’s more, researchers have also demonstrated that 71 percent of patients who took the pill version of semaglutide achieved a “clinically relevant” weight loss of 5 percent or more. The side effects of taking the pill form were comparable to those of the parenteral form of semaglutide.
The authors have concluded: “These findings support phase III studies to assess longer-term and clinical outcomes, as well as safety.” The next possible step is to test the effects of oral semaglutide in patients with higher levels of HbA1c.