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
Importance: Presently available glucagon-like peptide 1 receptor (GLP-1R) agonists to treat diabetes type 2 symptoms (T2D) are peptide agonists that require subcutaneous administration or strict fasting needs pre and publish dental administration.
Objective: To check out the effectiveness, safety, and tolerability of multiple dose amount novel, dental, small molecule GLP-1R agonist danuglipron over 16 days.
Design, setting, and participants: A phase 2b, double-blind, placebo-controlled, parallel-group, 6-group randomized medical study with 16-week double-blind treatment period and 4-week follow-up was conducted out of this summer time 7, 2020, for this summer time 7, 2021. Adults with T2D inadequately controlled by Danuglipron eating and working out, without or with metformin treatment, were enrolled from 97 clinical research sites in 8 countries or regions.
Interventions: Participants received placebo or danuglipron, 2.5, 10, 40, 80, or 120 mg, all orally administered two occasions daily with food for 16 days. Weekly dose escalation steps were incorporated to achieve danuglipron doses of 40 mg or maybe more two occasions daily.
Primary outcomes and measures: Change from baseline in glycated hemoglobin (HbA1c, primary finish point), fasting plasma glucose (FPG), and the entire body weight were assessed at week 16. Safety was monitored with the study period, plus a 4-week follow-up period.
Results: Of 411 participants randomized and treated (mean [SD] age, 58.6 [9.3] years 209 [51%] male), 316 (77%) completed treatment. For individuals danuglipron doses, HbA1c and FPG were statistically significantly reduced at week 16 versus placebo, with HbA1c reductions up to least squares mean difference versus placebo of -1.16% (90% CI, -1.47% to -.86%) for your 120-mg two occasions daily group and FPG reductions up to least squares mean difference versus placebo of -33.24 mg/dL (90% CI, -45.63 to -20.84 mg/dL). Bodyweight was statistically significantly reduced at week 16 as opposed to placebo inside the 80-mg two occasions daily and 120-mg two occasions daily groups only, getting a least squares mean difference versus placebo of -2.04 kg (90% CI, -3.01 to -1.07 kg) for your 80-mg two occasions daily group and -4.17 kg (90% CI, -5.15 to -3.18 kg) for your 120-mg two occasions daily group. Most likely probably the most generally reported adverse occasions were nausea, diarrhea, and vomiting.
Conclusions and relevance: In grown-ups with T2D, danuglipron reduced HbA1c, FPG, and the entire body weight at week 16 as opposed to placebo, getting a tolerability profile similar to the mechanism of action.