Study S000043

A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05691712
Acronym: SURPASS-CN-INS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 257
Start: 2023-02-05
Primary completion: 2024-07-01
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPIM

Registered primary outcomes

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) [Baseline, Week 40]

Linked records (1)

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
R0015125	Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Guo L, The lancet. Diabetes & endocrinology	2025	Randomized trial	PMID 41167231 DOI	cites ClinicalTrials.gov:NCT05691712; registry reference DERIVED:41167231