Protocol title: A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin degludec, both with or without non-insulin anti-diabetic drugs, in subjects (NN1436-4478)

JRCT ID: jRCT2031200421

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 05/03/2021
• Target sample size: 100
• Countries of recruitment: Bulgaria,Japan,Germany,Japan,Korea,Japan,Poland,Japan,Portugal,Japan,South Africa,Japan,Ukraine,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Two arm for insulin icodec and insulin degludec
The study will consist of 3 periods: a Screening Period, a -Treatment Period, and a Follow-Up Period.
Implementation of blood sampling tests, etc. specified in the protocol.

Outcome(s)

• Primary Outcome: The objective of this trial is to demonstrate the effect on glycaemic control of once weekly insulin icodec, with or without non-insulin anti-diabetic drugs, in subjects with T2D treated with basal insulin. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin degludec after 26 weeks of treatment to a non-inferiority limit of 0.3%.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male or female aged above or equal to 18 years at the time of signing informed consent.
2. Diagnosed with T2D >= 180 days prior to the day of screening.
3. HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
4. 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): >= 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses>= 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
5. Body mass index (BMI) <= 40.0 kg/m2.

Exclude criteria

1. Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
2. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
3. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
4. 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).
5. 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.

Related Information

• Primary Sponsor: Takase Juri
• Secondary ID(s): NCT04770532,2020-000454-10