Study S001385

A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03861039
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 443
Start: 2019-03-30
Primary completion: 2021-01-26
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Tirzepatide; DRUG:Oral antihyperglycemic medication (OAM)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-JE-GPGP

Registered primary outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Week 52]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0015987	Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Mimura H, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Other	PMID 40711720 DOI	cites ClinicalTrials.gov:NCT03861039; registry reference DERIVED:40711720
R0022282	Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Kadowaki T, The lancet. Diabetes & endocrinology	2022	Randomized trial	PMID 35914542 DOI	cites ClinicalTrials.gov:NCT03861039; registry reference DERIVED:35914542