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NCT05362058 (Insulin Efsitora Alfa Insulin… in Type 2 Diabetes): BVCT ex-ante prediction vs. reported outcome

On 26 Nov 2022, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (once-weekly is more convenient than SoC's once-daily dosage).

Clinical Trial

NCTID
NCT05362058
Acronym
QWINT-2
Drug Name
Insulin Efsitora Alfa (LY3209590) Insulin Degludec
Drug MoA
once-weekly insulin treatment
Drug Modality
protein biologic
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Type 2 Diabetes
Human Patients
928
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 721

Prospective Prediction
Prediction Index
721
Prediction Date
Commercial Prediction
SUCCESS (non-inferior)
Technical Prediction
SUCCESS

Readout of

Prediction Validation
Readout Date
Prediction To Readout
537 days in advance
Readout Data Interpretation
-1.34% (efsitora) vs -1.26% (degludec) HbA1C at week 52; non-inferior.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (once-weekly is more convenient than SoC's once-daily dosage)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 3
Status
Completed
Enrollment
928
Lead sponsor
Eli Lilly and Company
Conditions
Diabetes; Type 2 Diabetes
Interventions
DRUG: Insulin Efsitora Alfa; DRUG: Insulin Degludec
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-06-03
Primary completion
2024-04-10
Completion
2024-04-10
Results first posted
2025-05-16
Primary outcomes
  • Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] (Baseline, Week 52)

NCT05362058 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials