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
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT05352815
- Run by
- Novo Nordisk A/S
- People needed
- 1291
- Starts
- 2022-06-01
- Expected to finish
- 2024-04-23
- Last updated by the study team
- 2025-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Lenzmeier Fam Med CCT Research — Glendale, Arizona, United States
- Phoenician Centers for Research & Innovation PCRI — Phoenix, Arizona, United States
- Medical Investigations, Inc. — Little Rock, Arkansas, United States
- John Muir Physicians Network — Concord, California, United States
- Headlands Research California, LLC — Escondido, California, United States
- Scripps Whittier Diabetes Inst — La Jolla, California, United States
- Clinical Trials Research_Sacramento — Lincoln, California, United States
- Torrance Clin Res Inst, Inc. — Lomita, California, United States
- Pacific Clinical Studies — Los Alamitos, California, United States
- Downtown LA Res Ctr. Inc. — Los Angeles, California, United States
- Velocity Clin Res Los Angeles — Los Angeles, California, United States
- Valley Clinical Trials, Inc. — Northridge, California, United States
- Clinical Trials Research_Sacramento_0 — Sacramento, California, United States
- San Diego Family Care — San Diego, California, United States
- NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Creekside Endocrine Associates, PC — Denver, Colorado, United States
- Clinical Res Of W Florida Inc — Clearwater, Florida, United States
- Northeast Research Institute — Fleming Island, Florida, United States
- University of Miami — Miami, Florida, United States
- Adult Medicine of Lake County, Inc. — Mt. Dora, Florida, United States
- Suncoast Clin Res Port Richey — New Port Richey, Florida, United States
- Clinical Neuroscience Solution — Orlando, Florida, United States
- Florida Inst For Clin Res — Orlando, Florida, United States
- Pri Med Grp dba/Gil Ctr Fam — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.