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Clinical Trial Details

Trial ID: L3750
Source ID: NCT05813912
Associated Drug: Insulin Icodec
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
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Icodec|DRUG: Semaglutide
Outcome Measures: Primary: Change in glycated haemoglobin (HbA1c), Measured in percentage (%) points., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54) | Secondary: Change in mean 7-point self-measured plasma glucose (SMPG) profiles, Measured in millimoles per liter (mmol/L)., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)|Change in mean post-prandial glucose increment (over all meals), Measured in mmol/L., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)|Change in fasting plasma glucose (FPG), Measured in mmol/L., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)|Number of severe hypoglycaemic episodes (level 3), Measured in number of episodes., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)|Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 mmol/L [54 milligrams per deciliter {mg/dL}], confirmed by blood glucose [BG] meter), Measured in number of episodes., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL]), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Measured as number of episodes., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)|Change in body weight, Measured in kilograms (Kg)., From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)|Relative change in weekly insulin icodec dose, Measured in units (U)., From the week prior to intensification, week 25 (visit 27) to week 52 (visit 54)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 148
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-22
Completion Date: 2025-07-25
Results First Posted:
Last Update Posted: 2024-05-07
Locations: Edumed Broumov, Broumov, 550 01, Czechia|Edumed Broumov, Broumov, 550 01, Czechia|Diabetologické centrum s.r.o., Olomouc, 779 00, Czechia|DIALINE s.r.o., Plzeň 3, 301 00, Czechia|Diabet2 s.r.o., Praha 1, 110 00, Czechia|Diabet2 s.r.o., Praha 1, 110 00, Czechia|Comfort Care Praha s.r.o., Praha 4 - Chodov, 148 00, Czechia|Medicon a.s., Praha 4, 140 00, Czechia|EUC Klinika Praha a.s., Praha 5, 150 00, Czechia|Diabetologická a endokrinologická ambulance Praha, Praha, 140 21, Czechia|Hospital Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Hospital Miri, Sarawak, Miri, 98000, Malaysia|Universiti Teknologi MARA, Sungai Buloh Campus, Sungai Buloh, Selangor, 47000, Malaysia|Hospital Putrajaya, Putrajaya, Wilayah Persekutuan Putrajaya, 62250, Malaysia|Hospital Putrajaya, Putrajaya, Wilayah Persekutuan Putrajaya, 62250, Malaysia|Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski, Gorzow Wielkopolski, Lubuskie, 66-400, Poland|Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET, Krakow, Malopolskie, 31-261, Poland|Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET, Krakow, Malopolskie, 31-261, Poland|Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek, Tarnow, Malopolskie, 33-100, Poland|Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek, Tarnow, Malopolskie, 33-100, Poland|NBR Polska, Warszawa, Mazowieckie, 00-710, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, Wojewodztwo Lodzkie, 90-302, Poland|Osteo-Medic s.c. A. Racewicz, J. Supronik, Bialystok, 15-351, Poland|Centrum Badan Klinicznych PI-House, Gdansk, 80-546, Poland|NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o., Gdansk, 80-858, Poland|NZOZ Gdanska Poradnia Cukrzycowa, Gdansk, 80-858, Poland|Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski, Gorzow Wielkopolski, 66-400, Poland|Centrum Medyczne Pratia Katowice, Katowice, 40-081, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, 90-302, Poland|NBR Polska Tomasz Klodawski, Warszawa, 00-710, Poland|Poradnia Chorob Metabolicznych w Wierzchoslawicach, Wierzchoslawice, 33-122, Poland|Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis., Novi Sad, Vojvodina, 21000, Serbia|CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia|Clinical Hospital Centre Zemun, Belgrade, 11080, Serbia|Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department, Kragujevac, 34000, Serbia|King Chulalongkorn Memorial Hospital, Bangkok, 10330, Thailand|King Chulalongkorn Memorial Hospital, Bangkok, 10330, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Ramathibodi Hospital - Ped-Endo and Metabolism, Bangkok, 10400, Thailand|Ramathibodi Hospital - Ped-Endo and Metabolism, Bangkok, 10400, Thailand
URL: https://clinicaltrials.gov/show/NCT05813912