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
- Conditions
- Diabetes, Type 2
- Interventions
- Registration Number
- NCT06340854
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 404
- Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.
- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
- Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
- Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m^2).
- Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin glargine U100 Insulin icodec Participants will receive Insulin glargine subcutaneously once daily. Insulin icodec Insulin icodec Participants will receive Insulin icodec subcutaneously once weekly. Insulin icodec Insulin glargine Participants will receive Insulin icodec subcutaneously once weekly. Insulin glargine U100 Insulin glargine Participants will receive Insulin glargine subcutaneously once daily.
- Primary Outcome Measures
Name Time Method Change in glycated hemoglobin (HbA1c) From baseline (week 0) to week 26 Percentage point (%-point).
- Secondary Outcome Measures
Name Time Method Number of severe hypoglycaemic episodes (level 3) From baseline (week 0) to week 31 Number of episodes.
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) From baseline (week 0) to week 31 Number of episodes.
Time spent < 3.0 mmol/L (54 mg/dL) From week 22 to 26 % of time.
Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) From baseline (week -4 to 0) to week 22-26 Percentage (%) of time.
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction From baseline (week 0) to week 26 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.
Change in time spent > 10.0 mmol/L (180 mg/dL) From baseline (week-4 to 0) to week 22-26 % of time.
Mean weekly insulin dose From week 24 to week 26 Units (U).
Change in body weight From baseline (week 0) to week 26 Kilogram (kg).
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) From baseline (week 0) to week 31 Number of episodes.
Trial Locations
- Locations (70)
Advanced Investigative Medicine, Inc.
🇺🇸Hawthorne, California, United States
Scripps Whittier Diabetes Inst
🇺🇸La Jolla, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Northeast Research Institute of Florida
🇺🇸Fleming Island, Florida, United States
South Broward Research LLC
🇺🇸Miramar, Florida, United States
Endo Res Solutions Inc
🇺🇸Roswell, Georgia, United States
Cotton-Oneill Diabetes and End
🇺🇸Topeka, Kansas, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Jefferson City Medical Group, PC
🇺🇸Jefferson City, Missouri, United States
Univ of Nebraska Medical CTR
🇺🇸Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Southern NH Diabetes and Endo_Nashua
🇺🇸Nashua, New Hampshire, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Accellacare Wilmington
🇺🇸Wilmington, North Carolina, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Amarillo Medical Specialists
🇺🇸Amarillo, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Victorium Clinical Research
🇺🇸Houston, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Rainier Clin Res Ctr Inc
🇺🇸Renton, Washington, United States
"Medical Center Viva Feniks" Ood
🇧🇬Dobrich, Bulgaria
MHAT "Knyaginya Klementina" -Sofia EAD
🇧🇬Sofia, Bulgaria
UMHAT Aleksandrovska
🇧🇬Sofia, Bulgaria
Medical Institute of Ministry of interior
🇧🇬Sofia, Bulgaria
Medical centre Clinic Nova
🇧🇬Varna, Bulgaria
Medical centre Berbatov Beli drin
🇧🇬Yambol, Bulgaria
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
🇩🇪Münster, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
🇩🇪Münster, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
🇩🇪Oldenburg in Holstein, Germany
Institut für Diabetesforschung Osnabrück
🇩🇪Osnabrück, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
🇩🇪Wangen, Germany
Lifecare Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Belgaum Diabetes Centre
🇮🇳Belgaum, Karnataka, India
Manipal Hospital, Old Airport Road, Bengaluru
🇮🇳Bengaluru, Karnataka, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Malla Reddy Narayana Multispeciality Hospital
🇮🇳Hyderabad, Telangana, India
Gandhi Hospital & Medical college
🇮🇳Hyderabad, Telengana, India
Government Institute of Medical Sciences
🇮🇳Noida, Uttar Pradesh, India
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
🇮🇳Chandigarh, India
Christian Medical College and Hospital
🇮🇳Ludhiana, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳Puducherry, India
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
🇯🇵Shinjuku-ku, Tokyo, Japan
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Oyama East Clinic
🇯🇵Tochigi, Japan
Noritake Clinic
🇯🇵Ushiku-shi, Ibaraki, Japan
Uniwersytecki Szpital Kliniczny w Opolu
🇵🇱Opole, Opolskie, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱Warszawa, Poland
Trialmed CRS
🇵🇱Piotrków Trybunalski, Łódzkie, Poland
Advanced Clinical Research LLC
🇵🇷Bayamon, Puerto Rico
Manati Ctr For Clin Research
🇵🇷Manati, Puerto Rico
Hemant Makan
🇿🇦Johannesburg, Gauteng, South Africa
Dr Moosa's Rooms
🇿🇦Lenasia, Gauteng, South Africa
Botho ke Bontle Health Services
🇿🇦Pretoria, Gauteng, South Africa
Dr Mahesh Duki Research And Trial Site
🇿🇦Durban, KwaZulu Natal, South Africa
Dr A Amod
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr MB Moosa's Practice
🇿🇦Durban, KwaZulu-Natal, South Africa
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
ABS La Roca del Vallés
🇪🇸La Roca del Vallés, Spain
Hospital Clínico Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Quirón
🇪🇸Pozuelo de Alarcón, Spain