Lilly's investigational tirzepatide led to greater time in range compared to insulin degludec in adults with type 2 diabetes in SURPASS-3 CGM sub-study
Participants taking highest dose of tirzepatide experienced 91.2 per cent time in range (3.9-10 mmol/L) and 72.6 per cent time in tight target range (3.9-7.8 mmol/L)
CGM sub-study achieved its primary and secondary endpoints
TORONTO, Oct. 1, 2021 /CNW/ - At 52 weeks, three tirzepatide doses led to more time in tight target range (3.9-7.8mmol/L), improved glycemic variability and numerically less time in hypoglycemia compared to titrated insulin degludec in adults with type 2 diabetes in a continuous glucose monitoring (CGM) sub-study of Eli Lilly and Company's phase 3 SURPASS-3 clinical trial.i The CGM sub-study was presented at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting in an EASD-sponsored symposium.
The international consensus for time in range recommends a target of >70 per cent time in range (3.9-10 mmol/L) for most people with diabetes as well as a target of <4 per cent time below range 3.9 mmol/Land <25 per cent time above range 10 mmol/L.
"The CGM data collected through this SURPASS-3 sub-study show that tirzepatide helped participants have less variability in their blood glucose levels throughout the day, including spending less time below target range and more time in a tighter target range reflecting a normal blood glucose range," said Richard Bergenstal, M.D., Executive Director of the International Diabetes Center at Park Nicollet. "Improving glycemic variability, increasing time in range, and reducing time below range are important metrics in the management of type 2 diabetes because they reflect glucose control throughout the day, offering context beyond the three-month average of A1C."
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (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.
SURPASS-3 was a 52-week, multi-centre, randomized, phase 3, open-label trial evaluating the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg compared to titrated insulin degludec in adults with type 2 diabetes who have inadequate glycemic control on stable doses of metformin with or without an SGLT-2 inhibitor. Study participants were insulin-naïve and had a mean duration of diabetes of 8.4 years, a baseline A1C of 8.17 per cent and a baseline weight of 94.3 kg.
In the SURPASS-3 CGM sub-study, a subpopulation of 243 participants wore a CGM for 7 to 10 days at baseline, at 24 weeks and at 52 weeks to evaluate the effect of tirzepatide compared to insulin degludec on time in target ranges. Glycemic variability was measured during 24-hour periods by several measures, including the coefficient of variation (CV).
The CGM sub-study achieved its primary and secondary endpoints. Specifically, at 52 weeks, the primary endpoint showed that participants taking tirzepatide:
- Spent 72.6 per cent of the 24-hour period in tight target range (3.9-7.8 mmol/L) for pooled 10 mg and 15 mg arms, an average of approximately six more hours than those taking insulin degludec (48.0 per cent).
About tirzepatide
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP and GLP-1 are incretin molecules that increase insulin secretion postprandially. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).
About Diabetes
Approximately 11 million Canadians are living with diabetes or prediabetes. Roughly 90 per cent of people living with diabetes have type 2 diabetes.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more.
About Eli Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about tirzepatide as a potential treatment for patients with diabetes and reflects Lilly's current beliefs. However, as with any such undertakings, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that tirzepatide will prove to be a safe and effective treatment for diabetes, that tirzepatide will receive regulatory approvals or authorizations, or be commercially successful. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
REFERENCES
i Battelino, T. Effect of tirzepatide on glycaemic control captured with continuous glucose monitoring in patients with type 2 diabetes (SURPASS-3 CGM). Session S42a. Presented virtually at the 57th European Association for the Study of Diabetes Annual Meeting; September 27- October 1. |
SOURCE Eli Lilly Canada Inc.
Media Contact: Ethan Pigott, [email protected], 416-770-5843
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