A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
Summary
The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.
Timeline
- Start
- 2019-05-07
- Primary completion
- 2021-03-10
- Completion
- 2021-03-31
Outcome
Met primary endpoint
registry analysis (superiority test); 5 mg Tirzepatide vs 0.75 mg Dulaglutide; p <0.001; Least Squares Mean Difference -1.09 (95% CI -1.27 to -0.90); Mixed Models Analysis NCT03861052 ↗
registry analysis (superiority test); 10 mg Tirzepatide vs 0.75 mg Dulaglutide; p <0.001; Least Squares Mean Difference -1.27 (95% CI -1.45 to -1.08); Mixed Models Analysis NCT03861052 ↗
registry analysis (superiority test); 15 mg Tirzepatide vs 0.75 mg Dulaglutide; p <0.001; Least Squares Mean Difference -1.53 (95% CI -1.71 to -1.35); Mixed Models Analysis NCT03861052 ↗
paper Tirzepatide was superior compared with dulaglutide for glycaemic control and reduction in bodyweight. PMID 35914543 ↗
Publications
- Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25.
- Hamamoto Y, Oura T, Hirase T. Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis. Diabetes Ther. 2025 Apr;16(4):717-729. doi: 10.1007/s13300-025-01704-z. Epub 2025 Feb 14.
- Onishi Y, Oura T, Takeuchi M. Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis. Diabetes Ther. 2024 Mar;15(3):649-661. doi: 10.1007/s13300-024-01534-5. Epub 2024 Feb 4.
- Ishii H, Oura T, Takeuchi M. Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial. Diabetes Ther. 2023 Dec;14(12):2173-2183. doi: 10.1007/s13300-023-01485-3. Epub 2023 Oct 16.
- Inagaki N, Takeuchi M, Oura T, Imaoka T, Seino Y. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):623-633. doi: 10.1016/S2213-8587(22)00188-7. Epub 2022 Jul 30.
- Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dulaglutide | Peptide | 0.75 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 5 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |