Tirzepatide results published in The Lancet show superior A1C and body weight reductions compared to insulin glargine in adults with type 2 diabetes with increased cardiovascular risk
- A1C reduction: -2.24% (5 mg), -2.43% (10 mg), -2.58% (15 mg), -1.44% (insulin glargine)
- Weight change: -7.1 kg (-8.1%, 5 mg), -9.5 kg (-10.7%, 10 mg), -11.7 kg (-13.0%, 15 mg), +1.9 kg (+2.2%, insulin glargine)
- Percent of participants achieving A1C <7%: 81% (5 mg), 88% (10 mg), 91% (15 mg), 51% (insulin glargine)
- Percent of participants achieving A1C <5.7% (not controlled for type 1 error): 23% (5 mg), 33% (10 mg), 43% (15 mg), 3% (insulin glargine)
- A1C reduction: -2.11% (5 mg), -2.30% (10 mg), -2.41% (15 mg), -1.39% (insulin glargine)
- Weight change: -6.4 kg (5 mg), -8.9 kg (10 mg), -10.6 kg (15 mg), +1.7 kg (insulin glargine)
- Percent of participants achieving A1C <7%: 75% (5 mg), 83% (10 mg), 85% (15 mg), 49% (insulin glargine)
- The mean A1C values at 52 and 104 weeks were:
- At 52 weeks (N=1,750): 6.3% (5 mg), 6.1% (10 mg), 6.0% (15 mg), 7.1% (insulin glargine)
- At 104 weeks (N=199): 6.4% (5 mg), 6.1% (10 mg), 6.1% (15 mg), 7.5% (insulin glargine)
- The changes in body weight at 52 and 104 weeks were:
- At 52 weeks (N=1,755): -7.1 kg (-8.1%, 5 mg), -9.5 kg (-10.7%, 10 mg), -11.7 kg (-13.0%, 15 mg), +1.9 kg (+2.2%, insulin glargine)
- At 104 weeks (N=202): -5.8 kg (-8.6%, 5 mg), -10.4 kg (-10.8%, 10 mg), -11.1 kg (-12.8%, 15 mg), +2.3 kg (+2.3%, insulin glargine)
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 is a hormone that may complement the effects of GLP-1. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes, for chronic weight management and heart failure with preserved ejection fraction (HFpEF). It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH). About SURPASS-4 and the SURPASS clinical trial program
SURPASS-4 (NCT03730662) is a randomized, parallel, open-label trial comparing the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg to insulin glargine in adults with type 2 diabetes inadequately controlled with at least one and up to three oral antihyperglycemic medications (metformin, sulfonylureas or SGLT-2 inhibitors), who have increased cardiovascular (CV) risk. The trial randomized 2,002 study participants in a 1:1:1:3 ratio to receive either tirzepatide 5 mg, 10 mg or 15 mg or insulin glargine. Participants were located in the European Union,?North America?(Canada?and?the United States),?Australia,?Israel,?Taiwan?and?Latin America?(Brazil,?Argentina?and?Mexico). The primary objective of the study was to demonstrate that tirzepatide (10 mg and/or 15 mg) is non-inferior to insulin glargine for change from baseline A1C at 52 weeks in people with type 2 diabetes and increased CV risk.?The primary and key secondary endpoints were measured at 52 weeks, with participants continuing treatment up to 104 weeks or until study completion. The completion of the study was triggered by the accrual of major adverse cardiovascular events (MACE). Study participants enrolled had to have a mean baseline A1C between 7.5 percent and 10.5 percent and a BMI greater than or equal to 25 kg/m2?at baseline. All participants in the tirzepatide treatment arms started the study at a dose of tirzepatide 2.5 mg once-weekly and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5 mg (via a 2.5 mg step), 10 mg (via steps at 2.5 mg, 5 mg and 7.5 mg) or 15 mg (via steps at 2.5 mg, 5 mg, 7.5 mg, 10 mg and 12.5 mg). All participants in the titrated insulin glargine treatment arm started with a baseline dose of 10 units per day and titrated following a treat-to-target algorithm to reach a fasting blood glucose below 100 mg/dL. The SURPASS phase 3 global clinical development program for tirzepatide has enrolled more than 20,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies. The program began in late 2018, and all five global registration trials have been completed. About Diabetes Approximately 34 million Americans2?(just over 1 in 10) and an estimated 463 million adults worldwide3?have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in?the United States?alone2. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin. 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. For the latest updates, visit?http://www.lillydiabetes.com/?or follow us on Twitter:?@LillyDiabetes?and Facebook:?LillyDiabetesUS. About?Eli Lilly and Company
Lilly 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 a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at?lilly.com?and?lilly.com/newsroom. P-LLY Lilly Cautionary Statement Regarding Forward-Looking Statements
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 people with type 2 diabetes and the timeline for future readouts, presentations and other milestones relating to tirzepatide and its clinical trials and reflects Lilly's current belief and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that the studies will be completed as planned, that future study results will be consistent with the results to date or that tirzepatide will receive regulatory approvals.?For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1?Del Prato, S, et. al. (2021). Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.?The Lancet,?https://doi.org/10.1016/S0140-6736(21)02188-7. |
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2?Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020. |
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3?International Diabetes Federation. IDF Diabetes Atlas, 9th?edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at:?http://diabetesatlas.org. |
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i?Efficacy estimand represents efficacy prior to discontinuation of study drug or initiating rescue therapy for persistent severe hyperglycemia. |
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ii?Treatment differences for two estimands ? efficacy and treatment-regimen ? were evaluated for three tirzepatide doses (5 mg, 10 mg and 15 mg) compared to insulin glargine. |
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iii?Treatment-regimen estimand represents the efficacy irrespective of adherence to the investigational medicine or introduction of rescue therapy for persistent severe hyperglycemia. |
Refer to: |
Maggie Pfeiffer;?monson_maggie@lilly.com; 317-650-5939 (Media) |
Kevin Hern;?hern_kevin_r@lilly.com; 317-277-1838 (Investors) |
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