Study S000909

A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea

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

Registration

Registration: NCT04093752
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 917
Start: 2019-12-09
Primary completion: 2021-11-01
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Tirzepatide; DRUG:Insulin Glargine
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHO

Registered primary outcomes

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [Baseline, Week 40]

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
R0007363	Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups. Bi Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2024	Other trial	PMID 38494574 DOI	cites ClinicalTrials.gov:NCT04093752; registry reference DERIVED:38494574
R0019129	Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS-AP-Combo. Ma J, Diabetes, obesity & metabolism	2024	Other trial	PMID 38302718 DOI	cites ClinicalTrials.gov:NCT04093752
R0011858	Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial. Gao L, Nature medicine	2023	Randomized trial	PMID 37231074 DOI	cites ClinicalTrials.gov:NCT04093752; registry reference DERIVED:37231074