Study S000108

A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)

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

Registration

Registration: NCT04537923
Acronym: SURPASS-6
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 1428
Start: 2020-10-19
Primary completion: 2022-10-11
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Tirzepatide; DRUG:Insulin Lispro (U100)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHD; EUDRACT_NUMBER:2020-000284-23

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [Baseline, Week 52]

Linked records (3)

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
R0014253	Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6. Bajaj HS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2026	Other trial	PMID 41961454 DOI	cites ClinicalTrials.gov:NCT04537923; registry reference DERIVED:41961454
R0018632	Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6). Boye KS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2024	Randomized trial	PMID 39008236 DOI	cites ClinicalTrials.gov:NCT04537923
R0009666	Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. Rosenstock J, JAMA	2023	Randomized trial	PMID 37786396 DOI	cites ClinicalTrials.gov:NCT04537923; registry reference DERIVED:37786396