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A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Study acronym: ONWARDS 11
StatusActive, Not Recruiting
PhasePhase 3
Started2025-08-11
View on ClinicalTrials.gov ↗
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Amendment history 6 changes detected by DataLookout

2026-09-02
Enrollment closed, study ongoing
2026-09-02
Trial sites reduced: 198 → 182 locations
2026-06-30
Trial sites expanded: 193 → 196 locations
2026-04-07
Trial sites expanded: 184 → 193 locations
2026-04-07
Primary completion pushed: 2026-11-23 → 2027-01-25
2026-04-07
Completion pushed: 2026-12-28 → 2027-03-01
Trial Details
NCT Number NCT07076199
Lead Sponsor Novo Nordisk A/S
Conditions Diabetes Mellitus, Type 1
Enrollment 877 participants
Start Date 2025-08-11
Primary Completion 2027-01-25 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-01