Loading clinical trials...
Loading clinical trials...
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide 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 semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they 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 18 clinic visits, 34 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Univ of AL at Birmingham_BRM
Birmingham, Alabama, United States
Pri Med Grp dba/Gil Ctr Fam
Gilbert, Arizona, United States
Clinical Research Institute of Arizona
Sun City West, Arizona, United States
John Muir Physicians Network
Concord, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Velocity Clin Res Wstlke
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Northeast Res Inst. Inc.
Jacksonville, Florida, United States
Start Date
April 11, 2022
Primary Completion Date
December 13, 2023
Completion Date
January 16, 2024
Last Updated
July 9, 2025
683
ACTUAL participants
IcoSema
DRUG
Semaglutide 1 mg
DRUG
Lead Sponsor
Novo Nordisk A/S
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062