Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT05352815 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05352815
The ClinicalTrials.gov registry entry for NCT05352815 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,291 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05352815 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05352815?
The interventions under investigation include: Insulin icodec (DRUG), IcoSema (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05352815?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.