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Clinical Trial Details

Trial ID: L7160
Source ID: NCT06340854
Associated Drug: Insulin Icodec
Title: A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes, Type 2
Interventions: DRUG: Insulin icodec|DRUG: Insulin glargine
Outcome Measures: Primary: Change in glycated hemoglobin (HbA1c), Percentage point (%-point)., From baseline (week 0) to week 26 | Secondary: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)), Percentage (%) of time., From baseline (week -4 to 0) to week 22-26|Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction, DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contributes to 1 global score. Higher scores on the global score indicate greater satisfaction with treatment. Global score ranges 0- 36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment., From baseline (week 0) to week 26|Number of severe hypoglycaemic episodes (level 3), Number of episodes., From baseline (week 0) to week 31|Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter), Number of episodes., From baseline (week 0) to week 31|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), Number of episodes., From baseline (week 0) to week 31|Time spent < 3.0 mmol/L (54 mg/dL), % of time., From week 22 to 26|Change in time spent > 10.0 mmol/L (180 mg/dL), % of time., From baseline (week-4 to 0) to week 22-26|Mean weekly insulin dose, Units (U)., From week 24 to week 26|Change in body weight, Kilogram (kg)., From baseline (week 0) to week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 404
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-19
Completion Date: 2025-06-20
Results First Posted:
Last Update Posted: 2025-03-14
Locations: Advanced Investigative Medicine, Inc., Hawthorne, California, 90250, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Northeast Research Institute of Florida, Fleming Island, Florida, 32003, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|Cotton-Oneill Diabetes and End, Topeka, Kansas, 66606-2806, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Jefferson City Medical Group, PC, Jefferson City, Missouri, 65109, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198-3020, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89148, United States|Southern NH Diabetes and Endo_Nashua, Nashua, New Hampshire, 03060, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Accellacare Wilmington, Wilmington, North Carolina, 28401, United States|Trial Management Associates, Myrtle Beach, South Carolina, 29572, United States|Amarillo Medical Specialists, Amarillo, Texas, 79106, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Victorium Clinical Research, Houston, Texas, 77024, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|"Medical Center Viva Feniks" Ood, Dobrich, 9300, Bulgaria|MHAT "Knyaginya Klementina" -Sofia EAD, Sofia, 1233, Bulgaria|UMHAT Aleksandrovska, Sofia, 1431, Bulgaria|Medical Institute of Ministry of interior, Sofia, 1606, Bulgaria|Medical centre Clinic Nova, Varna, 9000, Bulgaria|Medical centre Berbatov Beli drin, Yambol, 8600, Bulgaria|InnoDiab Forschung GmbH, Essen, 45136, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin, Münster, 48153, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|Institut für Diabetesforschung Osnabrück, Osnabrück, 49080, Germany|Zentrum für klinische Studien Allgäu Oberschwaben, Wangen, 88239, Germany|Lifecare Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Belgaum Diabetes Centre, Belgaum, Karnataka, 590001, India|Manipal Hospital, Old Airport Road, Bengaluru, Bengaluru, Karnataka, 560017, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India|Grant Medical Foundation Ruby Hall Clinic, Pune, Maharashtra, 411001, India|Chellaram Diabetes Institute, Pune, Maharashtra, 411021, India|Malla Reddy Narayana Multispeciality Hospital, Hyderabad, Telangana, 500055, India|Gandhi Hospital & Medical college, Hyderabad, Telengana, 500003, India|Government Institute of Medical Sciences, Noida, Uttar Pradesh, 201310, India|Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Chandigarh, 160012, India|Christian Medical College and Hospital, Ludhiana, 141008, India|Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology, Shinjuku-ku, Tokyo, 1600023, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Noritake Clinic, Ushiku-shi, Ibaraki, 300-1207, Japan|Uniwersytecki Szpital Kliniczny w Opolu, Opole, Opolskie, 45-401, Poland|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|Centrum Medyczne Pratia Gdynia, Gdynia, Pomorskie, 81-338, Poland|Centrum Medyczne Pratia Katowice, Katowice, 40-081, Poland|Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warszawa, 02-507, Poland|Trialmed CRS, Piotrków Trybunalski, Łódzkie, 97-300, Poland|Advanced Clinical Research LLC, Bayamon, 00959, Puerto Rico|Manati Ctr For Clin Research, Manati, 00674, Puerto Rico|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Dr Moosa's Rooms, Lenasia, Gauteng, 1827, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, 0184, South Africa|Dr Mahesh Duki Research And Trial Site, Durban, KwaZulu Natal, 4339, South Africa|Dr A Amod, Durban, KwaZulu-Natal, 4092, South Africa|Dr MB Moosa's Practice, Durban, KwaZulu-Natal, 4092, South Africa|Hospital Clinic i Provincial, Barcelona, 08036, Spain|ABS La Roca del Vallés, La Roca del Vallés, 08430, Spain|Hospital Clínico Virgen de la Victoria, Málaga, 29010, Spain|Hospital Quirón, Pozuelo de Alarcón, 28223, Spain
URL: https://clinicaltrials.gov/show/NCT06340854

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress