Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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?
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, categorized as Phase 3. The registered enrollment target is 1,291 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (71% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
-
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
RECRUITING · Phase 3
-
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.