Taking all 3 doses also helped patients experience higher A1C levels than patients who took titrated insulin glargine, clinical trial results show.
Individuals with type 2 diabetes (T2D) with increased cardiovascular (CV) risk experienced superior A1C and body weight reductions when treated with all 3 doses of tirzepatide compared with titrated insulin glargine, results from a clinical trial by Eli Lilly and Company show.
"We are encouraged by the continued A1C and weight control that participants experienced past the initial 52-week treatment period and up to 2 years, as we continue to explore the potential impact of tirzepatide for the treatment of T2D," John Doupis, MD, PhD, director of diabetes division and clinical research center at Iatriko Paleou Falirou Medical Center, said in a statement.
At 52 weeks, the highest dose of tirzepatide led to an A1C reduction of 2.58% and reduced body weight by 13% compared with those treated with insulin glargine which had an A1C reduction of 1.44% and increased body weight of 2.2%.
During the phase 3 clinical trial, SURPASS-4, the primary endpoint measured at 52 weeks with individuals continuing treatment up to 104 weeks or until study completion.
Individuals taking tirzepatide maintained A1C and weight control for up to two years.
All 3 doses of tirzepatide, 5, 10, and 15 mg, led to statistically significant and superior A1C and body weight reductions.
Individuals in the study had a baseline of A1C of 8.52%, a baseline weight of 199.1 lbs, and a mean duration of diabetes of 11.8 years. More than 85% of the individuals had a history of cardiovascular events.
Individuals treated with the highest dose experienced a 5.6% decrease in cholesterol, a 7.9% decrease in low-density lipoprotein, a 21.8% decrease in very low-density protein, a 22.5% decrease in triglycerides, and a 10.8% increase in high-density lipoproteins.
Adverse events included diarrhea, nausea, and vomiting.
SURPASS-4 was an open-label global trial to compare the efficacy and safety of the 3 doses of tirzepatide to titrated insulin glargine in 2002 individuals with T2D who had increased cardiovascular risk.
Tirzepatide is a dual-dose dependent, investigational, novel, once-weekly insulinotropic polypeptide.
The results were published in The Lancet.
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. Lilly. News release. October 19, 2021. Accessed on October 20, 2021. https://investor.lilly.com/news-releases/news-release-details/tirzepatide-results-published-lancet-show-superior-a1c-and-body