Study S000095

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

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

Registration

Registration: NCT03987919
Acronym: SURPASS-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 1879
Start: 2019-07-30
Primary completion: 2021-01-28
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Tirzepatide; DRUG:Semaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPGL; EUDRACT_NUMBER:2018-004422-29; NIH:2018

Registered primary outcomes

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

Linked records (9)

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
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:NCT03987919; registry reference DERIVED:39531161
R0012919	Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Osumili B, Diabetes research and clinical practice	2024	Other trial	PMID 38777128 DOI	cites ClinicalTrials.gov:NCT03987919; registry reference DERIVED:38777128
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:NCT03987919; 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:NCT03987919; 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:NCT03987919; registry reference DERIVED:37668888
R0014630	Semaglutide versus tirzepatide for people with type 2 diabetes: cost of glycemic control in Austria, the Netherlands, Lithuania, and the United Arab Emirates. Reitzel SB, Current medical research and opinion	2023	Other trial	PMID 37415503 DOI	cites ClinicalTrials.gov:NCT03987919; registry reference DERIVED:37415503
R0012252	Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar N, Nature medicine	2022	Systematic review	PMID 35210595 DOI	cites ClinicalTrials.gov:NCT03987919; registry reference DERIVED:35210595
R0023137	Tirzepatide-Friend or Foe in Diabetic Cancer Patients? Samuel SM, Biomolecules	2022	Other trial	PMID 36358930 DOI	cites ClinicalTrials.gov:NCT03987919
R0013656	Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. Frías JP, The New England journal of medicine	2021	Randomized trial	PMID 34170647 DOI	cites ClinicalTrials.gov:NCT03987919; registry reference DERIVED:34170647