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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
Sponsor: Novo Nordisk A/S
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2023-09-22
Completion Date
2025-05-16
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Insulin Icodec
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
Semaglutide
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.
Locations (39)
Edumed Broumov
Broumov, Czechia
DIAMIN
Chrudim, Czechia
Diabetologické centrum s.r.o.
Olomouc, Czechia
DIALINE s.r.o.
Plzeň 3, Czechia
Diabet2 s.r.o.
Prague, Czechia
Medicon a.s.
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
DiaPodi care s.r.o.
Soběslav I, Czechia
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
Hospital Seri Manjung
Seri Manjung, Perak, Malaysia
Hospital Putrajaya
Putrajaya, Putrajaya, Malaysia
Hospital Miri
Miri, Sarawak, Malaysia
Universiti Teknologi MARA, Sungai Buloh Campus
Sungai Buloh, Selangor, Malaysia
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
Metabolica Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, Poland
Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
Tarnów, Lesser Poland Voivodeship, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
NBR Polska
Warsaw, Masovian Voivodeship, Poland
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Poland
NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
Gdansk, Poland
NZOZ Gdanska Poradnia Cukrzycowa
Gdansk, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Poland
Centrum Medyczne Pratia Katowice
Katowice, Poland
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Poland
NBR Polska Tomasz Klodawski
Warsaw, Poland
Poradnia Chorob Metabolicznych w Wierzchoslawicach
Wierzchosławice, Poland
Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu
Zabrze, Poland
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Łódź Voivodeship, Poland
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, Serbia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, Serbia
Clinical Hospital Centre Zemun
Belgrade, Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, Serbia
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Ramathibodi Hospital - Ped-Endo and Metabolism
Bangkok, Thailand