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

JRCT ID: jRCT2031240028

Registered date:12/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 19/04/2024
• Target sample size: 40
• Countries of recruitment: United States,Japan,India,Japan,Bulgaria,Japan,Germany,Japan,Poland,Japan,Spain,Japan,South Africa,Japan
• Study type: Interventional

Intervention(s)

After screening, all eligible participants will enter the blinded CGM run-in period at the run-in visit (V2). After the run-in period, participants will be randomised (1:1) to receive once-weekly insulin icodec or once-daily insulin glargine U100 at the randomisation visit (V6).

-an up to 2-week screening period
-a 4-week run-in period with CGM
-a 26-week intervention period
-a 5-week safety follow-up period

Insulin icodec should be taken once weekly, on the same day each week, at any time of the day. At randomisation visit (V6), all participants should receive a dose that is equivalent to their previous total daily basal insulin dose*7, rounded off to the nearest dose that is dividable by 10.
Insulin glargine U100 should be taken once daily, at any time of the day but at the same time every day throughout the study. Switching from another basal insulin should be in accordance with local label.

Outcome(s)

• Primary Outcome: Change in HbA1c: From baseline week 0 (V6) to week 40 (V32)
• Secondary Outcome: Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL):From baseline week -4-0 (V2-V6) to week 22-26 (V28-V32)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1, Diagnosed with Type 2 Diabetes greater than equal to (>=) 180 days prior to the day of screening.
2, HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
3, 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.
4, Body mass index (BMI) =< 40.0 kilogram per square meter (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 and until the start of runin. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Related Information

• Primary Sponsor: Tsukasaki Nobuaki
• Secondary ID(s): NCT06340854