Tirzepatide is a versatile peptide based on the GIP peptide sequence, although modified to bind to the GIP and GLP-1 receptors, it has a mean half-life of approximately 5 days, allowing it to be administered once a week. It said clinical trials in patients with type 2 diabetes have shown “very impressive data” and that the side effects (AE) profile is not significantly different from those reported with other molecules in the drug class. this
Another presenter summarized the results from the SURPASS trials, all of which showed favorable results with tirzepatide in different patient groups. The SURPASS-1 trial was a randomized, controlled, double-blind trial. We compared the results of tirzepatide with placebo in adults with uncontrolled type 2 diabetes. According to presenter Carol Wysham, MD, clinical professor of medicine at the University of Washington School of Medicine.
In the trial, 705 patients were screened and 478 were randomized between groups to receive tirzepatide or placebo. Within the tirzepatide group, patients received either 5 mg, 10 mg, or 15 mg. and all three doses were associated with a greater reduction in A1c compared to placebo.
Participants receiving the highest dose achieved a 2.7% reduction, and between 87% and 92% of tirzepatide-treated patients achieved an A1c goal of less than 7%. Taking tirzepatide was able to reduce weight of at least 15% of body weight and overall AE was balanced between groups. The only death occurred in the placebo group due to myocardial infarction, the researchers said.
Based on these findings, Wysham said, tirzepatide once a week helped manage inadequately controlled type 2 diabetes with diet and exercise alone. The researchers found that glycemic control was as strong as body weight. and normal blood sugar levels (defined as <5.7%) were successful in at least one-third of the participants.
The SURPASS-2 trial found similar satisfactory results when tirzepatide was compared with semaglutide once a week as an adjunct treatment to metformin in patients with type 2 diabetes. Approximately 470 patients were included in each of the four treatment groups, and Between 94% and 96% completed the study.
The discontinuation was slightly higher in the tirzepatide arm compared to the semaglutide arm, said Juan Frias, MD, medical director and principal investigator at the National Research Institute in Los Angeles. Most are caused by AE and most of the deaths are related to COVID-19.
A reduction in A1c was observed at week 4 in the tirzepatide group and ranged from -0.2% to -0.6% with the 15 mg dose compared to semaglutide. A greater proportion of tirzepatide patients achieved HbA1c of 40. a week compared to semaglutide and the proportion of patients in the tirzepatide arm achieving significant weight loss goals.
Based on these findings, Frias said once-weekly tirzepatide was shown to be superior and clinically meaningful improvements in blood sugar control as well as significant weight loss. Normoglycemia occurred in up to 51% of the participants.
Finally, Michelle Welch, MD, FACE, president of diabetes and metabolism specialists in San Antonio, discusses SURPASS-5, which compares the efficacy and safety of three doses of tirzepatide to placebo as an adjunct to insulin glargine. with or without metformin The participants had a mean age of 60, and 44% were female, 80% were Caucasian, and 18% were Asian. The median length of diabetes was 13.3 years with a baseline A1c of 8.3%.
During the 40-week study period, investigators observed a decrease of between 2.2% and 2.9% in the tirzepatide arm and in the titrated insulin glargine arm. With a reduction in the tirzepatide arm, between 8% and 32% of patients achieved a 15% or more reduction in weight.
All tirzepatide doses were superior to placebo at 40 weeks for changes from baseline in HbA1c as well as changes from baseline in body weight. The most common AEs with tirzepatide were gastrointestinal. Most were mild to moderate in severity. Welch concluded that in patients with type 2 diabetes treated with basal insulin glargine with or without metformin, tirzepatide is an effective treatment for improving glycemic control. blood and weight loss
Drucker agrees, adding that tirzepatide is a promising treatment.
Drucker concludes, “A lot of people are normalizing their blood sugar levels.”
Drucker D, Wysham C, Frias J, Giorgino F, Welch M. The next chapter in therapy. Incretin-Based–Tirzepatide A Novel Dual GIP/GLP-1 Receptor Agonist – Results From The First Phase 3 SURPASS Clinical Trial. Presented at the 81st Scientific Session of the American Diabetes Association June 29, 2021. Accessed June 29, 2021. https:/ /ada2021.org/live-stream/19772900/Next-Chapter-in-Incretin-Based-TherapiesTirzepatide-a-Novel-Dual-GIPGLP-1-Receptor-AgonistResults-from-the-First-Phase-3-SURPASS-Clinical -Trials-Includes-Live-Video-Question-and-Answer-Period