Study S002606

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05362058
Acronym: QWINT-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 928
Start: 2022-06-03
Primary completion: 2024-04-10
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes; Type 2 Diabetes
Interventions: DRUG:Insulin Efsitora Alfa; DRUG:Insulin Degludec
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8H-MC-BDCX; EUDRACT_NUMBER:2021-005891-21

Registered primary outcomes

Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] [Baseline, Week 52]

Linked records (1)

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
R0017651	Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. Wysham C, The New England journal of medicine	2024	Randomized trial	PMID 39254740 DOI	cites ClinicalTrials.gov:NCT05362058; registry reference DERIVED:39254740