Study S001608

Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

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

Registration

Registration: NCT04039503
Acronym: SURPASS-5
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 475
Start: 2019-08-30
Primary completion: 2020-12-22
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPGI; EUDRACT_NUMBER:2019-000860-99; NIH:2019

Registered primary outcomes

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

Linked records (7)

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:NCT04039503; registry reference DERIVED:41961454
R0010804	Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. De Block C, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 39531161 DOI	cites ClinicalTrials.gov:NCT04039503; registry reference DERIVED:39531161
R0007531	Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Boye KS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 37526908 DOI	cites ClinicalTrials.gov:NCT04039503; registry reference DERIVED:37526908
R0009342	Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Boye KS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 37668888 DOI	cites ClinicalTrials.gov:NCT04039503; registry reference DERIVED:37668888
R0012252	Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar N, Nature medicine	2022	Systematic review	PMID 35210595 DOI	cites ClinicalTrials.gov:NCT04039503; registry reference DERIVED:35210595
R0012480	Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. Dahl D, JAMA	2022	Randomized trial	PMID 35133415 DOI	cites ClinicalTrials.gov:NCT04039503; registry reference DERIVED:35133415
R0023137	Tirzepatide-Friend or Foe in Diabetic Cancer Patients? Samuel SM, Biomolecules	2022	Other trial	PMID 36358930 DOI	cites ClinicalTrials.gov:NCT04039503