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A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart 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 glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines 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 be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. 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
Lakeview Clinical Research, LLC
Guntersville, Alabama, United States
Valley Research
Fresno, California, United States
Scripps Wht Diab Inst La Jolla
La Jolla, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
San Diego Family Care
San Diego, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Creekside Endocrine Associates
Denver, Colorado, United States
Clinical Res Of W Florida Inc
Clearwater, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Start Date
November 30, 2021
Primary Completion Date
November 14, 2023
Completion Date
November 14, 2023
Last Updated
December 2, 2025
679
ACTUAL participants
IcoSema
DRUG
Insulin glargine
DRUG
insulin aspart
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