80-LB: Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist, Is Effective and Safe When Added to Basal Insulin for Treatment of Type 2 Diabetes (SURPASS-5)

Tirzepatide (TZP) is a novel dual GIP/GLP-1 receptor agonist in development for type 2 diabetes (T2D). Efficacy and safety of TZP vs. placebo (PBO) was assessed in people with T2D as an add-on to titrated insulin glargine with or without metformin. In this double-blind, PBO-controlled, 40-wk Phase 3 study, 475 people with T2D (mean baseline [BL] age 60.6 y; T2D duration 13.3 y; HbA1c 8.31%; BMI 33.4 kg/m2) were randomized (1:1:1:1) to TZP (5 mg, 10 mg, 15 mg) or PBO, as an add-on to their existing therapy. Primary efficacy measure was mean change in HbA1c from BL at 40 wk. Secondary measures included change in fasting serum glucose (FSG) and body weight (BW), and proportion of people achieving HbA1c and BW loss goals. All 3 TZP doses were superior to PBO in change from BL in HbA1c, FSG, BW, and percentage patients achieving all HbA1c and BW loss targets at 40 wk (Table). TZP was generally well tolerated and the most common AEs were gastrointestinal (diarrhea, nausea, and vomiting) and mild to moderate in severity. Level 2 hypoglycemia incidence (<54 mg/dL) did not differ between TZP and PBO. Three episodes of level 3 (severe) hypoglycemia were observed (2 episodes in TZP 10 mg and 1 in TZP 15 mg). TZP demonstrated superior and clinically meaningful improvements in glycemic control and BW loss without increasing hypoglycemia vs. PBO in patients with T2D when added to titrated basal insulin.View largeDownload slideView largeDownload slide DisclosureD. Dahl: Research Support; Self; Afimmune Limited, AstraZeneca, Eli Lilly and Company, Novartis AG, Novo Nordisk. Y. Onishi: Speaker's Bureau; Self; Daiichi Sankyo Company, Limited, Novo Nordisk, Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. P. Norwood: Other Relationship; Self; Eli Lilly and Company, Research Support; Self; Eli Lilly and Company. R. Huh: None. H. Patel: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. Á. Rodríguez: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company.FundingEli Lilly and Company