nctId: NCT06340854 id: NN1436-7724 id: U1111-1292-6151 type: OTHER domain: World Health Organization (WHO) id: 2023-506084-34 type: OTHER domain: European Medical Agency (EMA) briefTitle: 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 overallStatus: RECRUITING date: 2024-04-19 date: 2025-05-16 date: 2025-06-20 date: 2024-04-02 date: 2024-04-25 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months. conditions: Diabetes, Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 404 type: ESTIMATED name: Insulin icodec name: Insulin glargine measure: Change in glycated hemoglobin (HbA1c) measure: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction measure: Number of severe hypoglycaemic episodes (level 3) measure: 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) measure: 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) measure: Time spent < 3.0 mmol/L (54 mg/dL) measure: Change in time spent > 10.0 mmol/L (180 mg/dL) measure: Mean weekly insulin dose measure: Change in body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Investigative Medicine, Inc. status: RECRUITING city: Hawthorne state: California zip: 90250 country: United States lat: 33.9164 lon: -118.35257 facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: Clinical Trials Research status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Northeast Research Institute of Florida status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United 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Rose status: NOT_YET_RECRUITING city: Münster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: MedicalCenter am Clemenshospital status: NOT_YET_RECRUITING city: Münster zip: 48153 country: Germany lat: 51.96236 lon: 7.62571 facility: RED-Institut für medizinische Forschung und Fortbildung GmbH status: RECRUITING city: Oldenburg in Holstein zip: 23758 country: Germany lat: 54.29576 lon: 10.90156 facility: Institut für Diabetesforschung Osnabrück status: NOT_YET_RECRUITING city: Osnabrück zip: 49080 country: Germany lat: 52.27264 lon: 8.0498 facility: Zentrum für klinische Studien Allgäu Oberschwaben status: NOT_YET_RECRUITING city: Wangen zip: 88239 country: Germany lat: 48.72933 lon: 9.61175 facility: Lifecare Hospital and Research Centre status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560092 country: India lat: 12.97194 lon: 77.59369 facility: Belgaum Diabetes Centre status: NOT_YET_RECRUITING city: Belgaum state: Karnataka zip: 590001 country: India lat: 15.85212 lon: 74.50447 facility: Manipal Hospital, Old Airport Road, Bengaluru status: NOT_YET_RECRUITING city: Bengaluru state: Karnataka zip: 560017 country: India lat: 12.97194 lon: 77.59369 facility: Amrita Institute Of Medical Sciences & Research Centre status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682041 country: India lat: 9.93988 lon: 76.26022 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Grant Medical Foundation Ruby Hall Clinic status: NOT_YET_RECRUITING city: Pune state: Maharashtra zip: 411001 country: India lat: 18.51957 lon: 73.85535 facility: Malla Reddy Narayana Multispeciality Hospital status: NOT_YET_RECRUITING city: Hyderabad state: Telangana zip: 500055 country: India lat: 17.38405 lon: 78.45636 facility: Gandhi Hospital & Medical college status: NOT_YET_RECRUITING city: Hyderabad state: Telengana zip: 500003 country: India lat: 17.38405 lon: 78.45636 facility: Government Institute of Medical Sciences status: NOT_YET_RECRUITING city: Noida state: Uttar Pradesh zip: 201310 country: India lat: 28.58 lon: 77.33 facility: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: Christian Medical College and Hospital status: NOT_YET_RECRUITING city: Ludhiana zip: 141008 country: India lat: 30.91204 lon: 75.85379 facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) status: NOT_YET_RECRUITING city: Puducherry zip: 605006 country: India lat: 11.93381 lon: 79.82979 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokyo Medical Univ. 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