Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT04770532
Start Date
March 5 2021
End Date
March 1 2022
Last Update
December 15 2025
Active Locations (88)
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1
American Clinical Trials
Buena Park, California, United States, 90620
2
Cedars-Sinai Medical Group
Encino, California, United States, 91436
3
Valley Research
Fresno, California, United States, 93720
4
Diabetes/Lipid Mgmt & Res Ctr
Huntington Beach, California, United States, 92648