Study S002538

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

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

Registration

Registration: NCT05662332
Acronym: QWINT-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 795
Start: 2023-01-14
Primary completion: 2024-07-19
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes; T2D
Interventions: DRUG:Insulin Efsitora Alfa; DRUG:Insulin Glargine
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8H-MC-BDCW

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis] [Baseline, Week 52]

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