Study S001591

A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes

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

Registration

Registration: NCT03882970
Acronym: SURPASS-3
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 1444
Start: 2019-04-01
Primary completion: 2020-12-11
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Tirzepatide; DRUG:Insulin Degludec
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPGH; EUDRACT_NUMBER:2018-003422-84; NIH:2018

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [Baseline, Week 52]

Linked records (13)

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
R0012886	Liver Fat Changes in Patients With Type 2 Diabetes by Presence of Genetic Hepatic Steatosis: A Post Hoc Analysis of SURPASS-3 MRI. Cusi K, Liver international : official journal of the International Association for the Study of the Liver	2026	Other trial	PMID 42576670 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:42576670
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:NCT03882970; registry reference DERIVED:39531161
R0016482	Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial. Sattar N, The lancet. Diabetes & endocrinology	2025	Randomized trial	PMID 40318682 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:40318682
R0020832	Effect of tirzepatide on body fat distribution pattern in people with type 2 diabetes. Cariou B, Diabetes, obesity & metabolism	2024	Other	PMID 38528819 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:38528819
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:NCT03882970; registry reference DERIVED:37526908
R0007660	Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Viljoen A, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Randomized trial	PMID 37000390 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:37000390
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:NCT03882970; registry reference DERIVED:37668888
R0011324	Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Gastaldelli A, The lancet. Diabetes & endocrinology	2022	Randomized trial	PMID 35468325 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:35468325
R0012252	Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar N, Nature medicine	2022	Systematic review	PMID 35210595 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:35210595
R0018763	Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Battelino T, The lancet. Diabetes & endocrinology	2022	Randomized trial	PMID 35468321 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:35468321
R0023137	Tirzepatide-Friend or Foe in Diabetic Cancer Patients? Samuel SM, Biomolecules	2022	Other trial	PMID 36358930 DOI	cites ClinicalTrials.gov:NCT03882970
R0039135	728-P: Glycemic Variability of Tirzepatide vs. Insulin Degludec in People with Type 2 Diabetes Using Continuous Glucose Monitoring (SURPASS-3 CGM) Richard M. Bergenstal, Diabetes	2022	Other	DOI	cites ClinicalTrials.gov:NCT03882970
R0017801	Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Ludvik B, Lancet (London, England)	2021	Randomized trial	PMID 34370970 DOI	cites ClinicalTrials.gov:NCT03882970; registry reference DERIVED:34370970