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NCT05823948 · ClinicalTrials.gov registry record · Phase 3
A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT05823948: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
NCT05823948 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 51 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05823948, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be injected with a needle in a skin fold in the thigh, upper arm, or stomach. The study will last for about 8 months. Participants will have to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Primary Outcome
Change in HbA1c from week 0 to week 26 is presented in percentage-point.
Conditions Studied
Interventions
- DRUG Insulin Icodec
Study Locations (20)
Texas
- Amarillo Medical Specialists - Amarillo
- Velocity Clin Res, Dallas - Dallas
- UT Southwestern Med Cntr - Dallas
- Fmc Science, Llc - Lampasas
- Clinical Trials of Texas Inc - San Antonio
- Northeast Clinical Research of San Antonio - San Antonio
California
- Desert Oasis Hlthcr Med Group - Palm Springs
- Clinical Trials Research_Sacramento_0 - Sacramento
- San Diego Family Care - San Diego
- Mills-Peninsula Hlth Services - San Mateo
Florida
- Florida Inst For Clin Res LLC - Orlando
- Metabolic Research Institute Inc - West Palm Beach
Hawaii
- East West Med Res Inst - Honolulu
Michigan
- Northern Pines Hlth Ctr, PC - Buckley
Minnesota
- International Diabetes Center - Minneapolis
Nevada
- Palm Research Center Inc-Vegas - Las Vegas
North Carolina
- Accellacare_NC - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-04-11 |
| Est. Completion | 2024-04-11 |
| Phase | Phase 3 |
What the finished NCT05823948 record still lists
NCT05823948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Insulin Icodec is the first listed.
NCT05823948 names 20 study sites across 11 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05823948 about?
NCT05823948 is a clinical study titled "A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)". This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash...
What is the current status of trial NCT05823948?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2023-04-11. Estimated completion is 2024-04-11.
What conditions does trial NCT05823948 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05823948?
The interventions under investigation include: Insulin Icodec (DRUG).
Who is sponsoring clinical trial NCT05823948?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05823948 being conducted?
This trial has 20 study locations across California, Florida, Hawaii, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05823948's enrollment target sits among peer trials
51 257th of 348 higher than 91 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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