Results from four clinical studies identify potential new treatment option for people with type 2 diabetes
Data from the SURPASS global clinical development program for Eli Lilly and Company’s tirzepatide, a novel investigational once-weekly medication for the treatment of type 2 diabetes, demonstrates statistically significant A1C and weight reductions versus several comparators. Findings of global registration trials, SURPASS-1, SURPASS-2, SURPASS-3, and SURPASS-5 were presented at the virtual 81st Scientific Sessions of the American Diabetes Association® (ADA). The SURPASS-1 study was be simultaneously published in The Lancet and SURPASS-2 was simultaneously published in The New England Journal of Medicine.
For patients with diabetes, high blood glucose levels and being overweight translates to greater risk of developing complications. Blood glucose levels over the past two to three months can be measured with a test called A1C. With more than 34 million Americans living with diabetes and 78% of people with diabetes considered to have obesity, there is an ongoing need for solutions to help patients manage weight and meet their full treatment needs.
Tirzepatide is a novel, once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of the GIP and GLP-1 incretins into a single molecule, representing a new class of medicines for the treatment of type 2 diabetes. Tirzepatide is under development and in phase three of clinical trials for the treatment of type 2 diabetes.
Each SURPASS trial was designed to provide insights into tirzepatide’s potential as a treatment for type 2 diabetes. SURPASS-1 evaluated the efficacy and safety of three tirzepatide doses (5 mg, 10 mg, and 15 mg) as monotherapy against placebo among people with type 2 diabetes. SURPASS-2 and SURPASS-3 compared the efficacy and safety of the same three doses of tirzepatide to injectable semaglutide 1 mg and insulin degludec, respectively. SURPASS-5 evaluated the efficacy and safety of tirzepatide as an add-on to insulin glargine compared to placebo.
In each study, tirzepatide achieved its primary and key secondary endpoints for the efficacy estimand and delivered consistent safety and efficacy with sustained A1C reduction and progressive weight loss among people with type 2 diabetes:
- In SURPASS-1, all three tirzepatide doses demonstrated statistically significant and clinically meaningful improvements in A1C and body weight reductions compared to placebo. Up to 92% of participants on tirzepatide achieved an A1C of less than 7%—the ADA’s recommended target for most people with diabetes. Up to 52% achieved an A1C of less than 5.7%—the level for people without diabetes.
- In SURPASS-2, all three tirzepatide doses delivered superior A1C and body weight reductions from baseline compared to semaglutide. Up to 92% of participants on tirzepatide achieved an A1C of less than 7% and up to 51% achieved an A1C less than 5.7%.
- In SURPASS-3, all three tirzepatide doses delivered superior A1C and body weight reductions from baseline compared to titrated insulin degludec. Up to 93% of participants on tirzepatide achieved an A1C of less than 7% and up to 48% achieved an A1C of less than 5.7%.
- In SURPASS-5, all three tirzepatide doses delivered superior A1C reductions and weight reductions compared to placebo both added to titrated insulin glargine. Up to 97% of participants on tirzepatide achieved an A1C of less than 7% and up to 62% of participants on tirzepatide achieved an A1C of less than 5.7%.
“Collectively, the SURPASS study results exceeded our expectations and point toward tirzepatide’s efficacy in people living with type 2 diabetes at different stages of their treatment journeys,” said Laura Fernández Landó, M.D., Senior Medical Director of tirzepatide for type 2 diabetes at Eli Lilly and Company. “Tirzepatide is delivering unprecedented results that could help millions of people with type 2 diabetes and their health care providers reach A1C and weight goals—both key measures of diabetes management.”
The studies presented at the ADA’s 81st Scientific Sessions are part of the SURPASS global clinical development program, which has enrolled more than 19,000 people with type 2 diabetes across ten clinical trials, five of which are global registration studies.
Research presentation details:
- Study investigators presented the findings of the SURPASS trial during the sessions listed below (all sessions will be recorded and accessible for 90 days):
- NOTE: Embargo lifts for SURPASS-2, SURPASS-3 and SURPASS-5 late breaking posters on Friday, June 25 at 11:30 a.m. ET
- Date: Saturday, June 26 at 4:00 p.m. ET: SURPASS-1 Oral Presentation
- Date: Tuesday, June 29, 8:00–9:30 a.m. ET: Symposium—Next Chapter in Incretin-Based Therapies—Tirzepatide, a Novel Dual GIP/GLP-1 Receptor Agonist—Results from the First Phase 3 SURPASS Clinical Trials
- Dr. Landó will be providing an overview of the study findings and available for virtual media interviews on June 29 from 11:00 a.m.–12:00 p.m. ET.
For more information or to request an interview with Dr. Landó, please contact the ADA Scientific Sessions media team at SciSessionsPress@diabetes.org.
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About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).
About the ADA’s Scientific Sessions
The ADA’s 81st Scientific Sessions, the world’s largest scientific meeting focused on diabetes research, prevention, and care, will be held virtually June 25–29. Leading physicians, scientists, and health care professionals from around the world will unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Though the conference will be remote this year, attendees will receive exclusive access to nearly 2,000 original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Learn more and register at scientificsessions.diabetes.org and join the Scientific Sessions conversation on social media using #ADA2021.
