Eli Lilly has announced that the SURPASS-2 clinical trial has shown tirzepatide achieved superior HbA1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.
Results from the trial have been published in The New England Journal of Medicine and will be presented in a late breaking poster presentation during the American Diabetes Association’s 81st Scientific Sessions.
The data show that all three tirzepatide doses achieved greater HbA1C and weight reductions compared to semaglutide 1 mg.
Additionally, a prespecified exploratory composite endpoint comprised of participants who achieved an HbA1C level less than or equal to 6.5% and weight loss of 10% or greater, while not experiencing hypoglycaemia less than 54 mg/dL or severe hypoglycaemia, was evaluated. Across the three doses of tirzepatide, 32% (5 mg), 51% (10 mg) and 60% (15 mg) of participants achieved this composite endpoint compared to 22% of participants taking semaglutide 1 mg.
Melanie Davies, Professor of Diabetes Medicine at University of Leicester, NIHR Senior Investigator Emeritus, and Principal Investigator of SURPASS-2, said: “Head-to-head data like these are very exciting, and underscore that, if approved, tirzepatide may be a promising new treatment option for people with Type 2 diabetes here in the UK.”
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of Type 2 diabetes. Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide approved by the EMA for the treatment of Type 2 diabetes.
Dr Kunal Gulati, Senior Medical Lead Diabetes at Lilly Northern Europe, said: “These data suggest that tirzepatide has the potential to be a new treatment option to help people with Type 2 diabetes better manage HbA1C and weight.”
The study randomised 1,879 participants, who had a mean duration of diabetes of 8.6 years, a baseline HbA1C of 8.28% and a baseline weight of 93.7 kg.
For both estimands, all three doses of tirzepatide demonstrated superior HbA1C and body weight reductions compared to semaglutide 1 mg. Specifically, the efficacy estimand results showed:
- HbA1C reduction: -2.09% (5 mg), -2.37% (10 mg), -2.46% (15 mg), -1.86% (semaglutide 1 mg)
- Weight reduction: -7.8 kg (5 mg), -10.3 kg (10 mg), -12.4 kg (15 mg), -6.2 kg (semaglutide 1 mg)
- Percent of participants achieving HbA1C <7%: 85% (5 mg), 89% (10 mg), 92% (15 mg), 81% (semaglutide 1 mg)
- Percent of participants achieving HbA1C <5.7%: 29% (5 mg, not controlled for type 1 error), 45% (10 mg), 51% (15 mg), 20% (semaglutide 1 mg)
SURPASS-2 is the second of five global registration studies for tirzepatide in type 2 diabetes, all of which have been completed. Lilly intends to submit the full registration package to regulatory authorities by the end of 2021.
Kat Jenkins
This is a syndicated feed from Pharmafile
