drugset / Trial / NCT03987919

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

NCT03987919 ↗

Phase 3 Completed 1879 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Timeline

Start
2019-07-30
Primary completion
2021-01-28
Completion
2021-02-15

Outcome

Met primary endpoint

registry analysis (superiority test); 10 mg Tirzepatide vs 1 mg Semaglutide; p <0.001; LS Mean Difference -0.51 (95% CI -0.64 to -0.38); Mixed Models Analysis NCT03987919 ↗

registry analysis (superiority test); 15 mg Tirzepatide vs 1 mg Semaglutide; p <0.001; LS Mean Difference -0.60 (95% CI -0.73 to -0.47); Mixed Models Analysis NCT03987919 ↗

paper Tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks. PMID 34170647 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Semaglutide Peptide 1 mg Subcutaneous
Subject Tirzepatide Peptide 5 mg Subcutaneous
Subject Tirzepatide Peptide 10 mg Subcutaneous
Subject Tirzepatide Peptide 15 mg Subcutaneous