Status:
COMPLETED
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes. Participants will get insulin icodec once a week for 6 ...
Eligibility Criteria
Inclusion
- Chinese male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 18 and 38 kg/m\^2 (both inclusive)
- HbA1c (glycated haemoglobin) below or equal to 9% at screening
- Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 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 60 days prior to the day of screening:
- Any metformin formulation
- Other oral antidiabetic drugs: DPP-4 (Dipeptidyl-peptidase-4) Inhibitors , SGLT2 (Sodium-glucose co-transporter-2) inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs)
- Oral or injectable GLP-1 (Glucagon Like Peptide 1) Receptor Agonists
Exclusion
- Known or suspected hypersensitivity to trial product(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and run-in. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04857398
Start Date
April 28 2021
End Date
April 6 2022
Last Update
May 17 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100853