A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin
Launched by NOVO NORDISK A/S · Feb 22, 2021
Trial Information
Current as of May 12, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female aged above or equal to 18 years at the time of signing informed consent.
- • Diagnosed with T2D greater than or 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 units/mL, or insulin glargine 300 units/mL): greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:
- • Metformin
- • Sulfonylureas
- • Meglitinides (glinides)
- • DPP-4 inhibitors
- • SGLT2 inhibitors
- • Thiazolidinediones
- • Alpha-glucosidase inhibitors
- • Oral combination products (for the allowed individual oral anti-diabetic drugs)
- • Oral or injectable GLP-1-receptor agonists
- • Body mass index (BMI) below or equal to 40.0 kg/m\^2.
- Exclusion Criteria:
- • Any episodes (as declared by the subject or in the medical records) 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.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Walnut Creek, California, United States
Fresno, California, United States
New Orleans, Louisiana, United States
La Jolla, California, United States
Hamburg, , Germany
Rehlingen Siersburg, , Germany
Waltham, Massachusetts, United States
Olympia, Washington, United States
Greensboro, North Carolina, United States
Dallas, Texas, United States
Münster, , Germany
Plovdiv, , Bulgaria
Seoul, , Korea, Republic Of
Walnut Creek, California, United States
Sofia, , Bulgaria
Durban, Kwazulu Natal, South Africa
Fresno, California, United States
Hohenmölsen, , Germany
Poznan, , Poland
San Antonio, Texas, United States
Wilmington, North Carolina, United States
Northridge, California, United States
Roswell, Georgia, United States
Warszawa, , Poland
Bloemfontein, Free State, South Africa
Port Elizabeth, Eastern Cape, South Africa
Rockville, Maryland, United States
Seoul, , Korea, Republic Of
Johannesburg, Gauteng, South Africa
Waco, Texas, United States
San Antonio, Texas, United States
Palm Springs, California, United States
Slidell, Louisiana, United States
Pembroke Pines, Florida, United States
New Orleans, Louisiana, United States
Sugar Land, Texas, United States
Sapporo Shi, Hokkaido, , Japan
Seoul, , Korea, Republic Of
Amarillo, Texas, United States
Seoul, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Lodz, , Poland
Matosinhos, , Portugal
Northridge, California, United States
Seoul, , Korea, Republic Of
Fort Worth, Texas, United States
Ocala, Florida, United States
Houston, Texas, United States
Waltham, Massachusetts, United States
Essen, , Germany
Almada, , Portugal
Porto, , Portugal
Ibaraki, , Japan
Miyazaki, , Japan
Suwon Si, Gyeonggi Do, , Korea, Republic Of
Lincoln, California, United States
Port Elizabeth, Eastern Cape, South Africa
Buena Park, California, United States
Almada, , Portugal
Essen, , Germany
Kyiv, , Ukraine
Ocala, Florida, United States
Tokyo, , Japan
Tochigi, , Japan
Buena Park, California, United States
Albany, New York, United States
Porto, , Portugal
Chigasaki Shi, Kanagawa, , Japan
Fukuoka Shi, Fukuoka, , Japan
Dnipro, , Ukraine
Valparaiso, Indiana, United States
Vila Nova De Gaia, , Portugal
Waco, Texas, United States
Stuttgart, , Germany
Lisboa, , Portugal
Gyeonggi Do, , Korea, Republic Of
Chiba, , Japan
Ushiku Shi, Ibaraki, , Japan
Kyustendil, , Bulgaria
Ruse, , Bulgaria
Ternopil, , Ukraine
Sugar Land, Texas, United States
Wilmington, North Carolina, United States
Chigasaki Shi, Kanagawa, Kanagawa, Japan, Japan
Miyazaki Shi, Miyazaki, Japan, Japan
Lodz, , Poland
Chiba, , Japan
Warszawa, , Poland
Palm Springs, California, United States
Roswell, Georgia, United States
Albany, New York, United States
Greensboro, North Carolina, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Olympia, Washington, United States
Hamburg, , Germany
Münster, , Germany
Stuttgart, , Germany
Ibaraki, , Japan
Lincoln, California, United States
Fort Worth, Texas, United States
Johannesburg, Gauteng, South Africa
Durban, Kwazulu Natal, South Africa
Kyiv, , Ukraine
La Jolla, California, United States
Slidell, Louisiana, United States
Kyustendil, , Bulgaria
Sofia, , Bulgaria
Fukuoka Shi, Fukuoka, , Japan
Seoul, , Korea, Republic Of
Lisboa, , Portugal
Vila Nova De Gaia, , Portugal
Miramar, Florida, United States
Johannesburg, Gauteng, South Africa
Rockville, Maryland, United States
Valparaiso, Indiana, United States
Tochigi, , Japan
Tokyo, , Japan
Poznan, , Poland
Johannesburg, Gauteng, South Africa
Ternopil, , Ukraine
Bloemfontein, Free State, South Africa
Miyazaki Shi, Miyazaki, Japan
Ruse, , Bulgaria
Hohenmölsen, , Germany
Chigasaki Shi, Kanagawa, Japan, Japan
Ushiku Shi, Ibaraki, , Japan
Porto, , Portugal
Dnipro, , Ukraine
Sapporo Shi, Hokkaido, , Japan
Stuttgart, , Germany
Lodz, , Poland
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Plovdiv, , Bulgaria
Rehlingen Siersburg, , Germany
Kyiv, , Ukraine
Patients applied
Trial Officials
Clinical Transparency (dept. 1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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