6/28/23, 11:45 PM Oral GLP-1 (danuglipron 120 mg) Pathway Feedback Search Clinical Topics Home Studies Oral GLP 1 (danuglipron 120 mg) Oral GLP 1 (danuglipron 120 mg) Disease Diabetes mellitus type 2 Trial question What is the effect of danuglipron in patients with T2DM? Study design Multi-center Double blinded RCT Population Characteristics of study participants 51.0% female N = 137 49.0% male 137 patients (70 female, 67 male) Inclusion criteria: adults with T2DM inadequately controlled by diet and exercise, with or without metformin treatment Key exclusion criteria: T1DM; secondary form of diabetes; recent history of cardiovascular events; gastrointestinal conditions possibly affecting drug absorption; medullary thyroid carcinoma Interventions N=71 danuglipron (at an oral dose of 120 mg BID with food for 16 weeks) N=66 placebo (matching placebo BID) Primary outcome Reduction in glycated hemoglobin at week 16 https://web.pathway.md/studies/recH8dX6e1Ne0gUK8 1/2 6/28/23, 11:45 PM Oral GLP-1 (danuglipron 120 mg) Pathway 1.2 % 1.18 0.9 % 0.6 % Significant increase 0.3 % NNT = 86 0.02 0.0 % Danuglipron Placebo Significant increase in reduction in glycated Hgb at week 16 (1.18% vs. 0.02%; MD 1.16, 90% CI 0.86 to 1.47) Secondary outcomes Significant increase in reduction in fasting plasma glucose at week 16 (31.93 mg/dL vs. -1.31 mg/dL; MD 33.24, 90% CI 20.84 to 45.63) Significant increase in reduction in body weight at week 16 (4.6 kg vs. 0.43 kg; MD 4.17, 90% CI 3.18 to 5.15) Conclusion In adults with T2DM inadequately controlled by diet and exercise, with or without metformin treatment, danuglipron was superior to placebo with respect to reduction in glycated Hgb at week 16. Reference Aditi R Saxena, Juan P Frias, Lisa S Brown et al. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314493. Open reference URL https://web.pathway.md/studies/recH8dX6e1Ne0gUK8 2/2