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Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. 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
Edumed Broumov
Broumov, Czechia
DIALINE s.r.o.
Plzeň 3, Czechia
Diabet2 s.r.o.
Prague, Czechia
Diabetologická a endokrinologická ambulance Praha
Prague, Czechia
EUC Klinika Praha a.s.
Prague, Czechia
Comfort Care Praha s.r.o.
Praha 4 - Chodov, Czechia
Hospital Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, Malaysia
Hospital Putrajaya
Putrajaya, Putrajaya, Malaysia
Hospital Miri
Miri, Sarawak, Malaysia
Universiti Teknologi MARA, Sungai Buloh Campus
Sungai Buloh, Selangor, Malaysia
Start Date
September 22, 2023
Primary Completion Date
April 14, 2025
Completion Date
May 16, 2025
Last Updated
August 17, 2025
148
ACTUAL participants
Insulin Icodec
DRUG
Semaglutide
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