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NCT05352815 · ClinicalTrials.gov registry record · Phase 3
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,291
- Enrollment target
- 20
- Study locations
NCT05352815: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
NCT05352815 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,291 participants, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05352815, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,291 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.
Primary Outcome
Change from baseline (week 0) to week 52 in HbA1c is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died befo
Conditions Studied
Interventions
- DRUG Insulin icodec
- DRUG IcoSema
Study Locations (20)
California
- John Muir Physicians Network - Concord
- Headlands Research California, LLC - Escondido
- Scripps Whittier Diabetes Inst - La Jolla
- Clinical Trials Research_Sacramento - Lincoln
- Torrance Clin Res Inst, Inc. - Lomita
- Pacific Clinical Studies - Los Alamitos
- Downtown LA Res Ctr. Inc. - Los Angeles
- Velocity Clin Res Los Angeles - Los Angeles
- Valley Clinical Trials, Inc. - Northridge
- Clinical Trials Research_Sacramento_0 - Sacramento
- San Diego Family Care - San Diego
- NorCal Endocrinology and Internal Medicine - San Ramon
- Diablo Clinical Research, Inc. - Walnut Creek
Arizona
- Pri Med Grp dba/Gil Ctr Fam - Gilbert
- Lenzmeier Fam Med CCT Research - Glendale
- Phoenician Centers for Research & Innovation PCRI - Phoenix
Florida
- Clinical Res Of W Florida Inc - Clearwater
- Northeast Research Institute - Fleming Island
Arkansas
- Medical Investigations, Inc. - Little Rock
Colorado
- Creekside Endocrine Associates, PC - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,291 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2024-04-23 |
| Phase | Phase 3 |
What the finished NCT05352815 record still lists
NCT05352815 is an interventional study that assigns participants to a tested intervention. Its 1,291 participants enrollment target places it among the larger protocols in the corpus, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Insulin icodec is the first listed.
NCT05352815 names 20 study sites across 5 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05352815 about?
NCT05352815 is a clinical study titled "A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec". This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compar...
What is the current status of trial NCT05352815?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,291 participants. The study started on 2022-06-01. Estimated completion is 2024-04-23.
What conditions does trial NCT05352815 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05352815?
The interventions under investigation include: Insulin icodec (DRUG), IcoSema (DRUG).
Who is sponsoring clinical trial NCT05352815?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05352815 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. 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 NCT05352815's enrollment target sits among peer trials
1,291 24th of 348 higher than 325 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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