A research study to see how well new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar levels in people with type 2 diabetes, compared to daily insulin glargine(NN1535-4988:COMBINE 4)

JRCT ID: jRCT2031230600

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 15/02/2024
• Target sample size: 60
• Countries of recruitment: United States,Japan,China,Japan,Greece,Japan,India,Japan,Italy,Japan,Poland,Japan,South Africa,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Participants will be randomised (1:1) to receive once weekly IcoSema or once daily insulin glargine.
-up to 2 weeks screening period
-a 40-week treatment period
-a 5-week follow-up period
IcoSema should be taken once weekly at the same day of the week. The starting dose at randomisation (V2) will be 40 dose steps, which is equivalent to 40 units of insulin icodec and 0.114 mg of semaglutide. The maximum dose of IcoSema is 350 dose steps.
Insulin glargine should be taken once daily at the same time every day. The starting dose should be 10U per day. There is no minimum or maximum dose of insulin glargine.

Outcome(s)

• Primary Outcome: Change in HbA1c: From baseline week 0 (V2) to week 40 (V42)
• Secondary Outcome: Change in body weight: From baseline week 0 (V2) to week 40 (V42)

Key inclusion & exclusion criteria

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

Include criteria

1. Male or female and age above or equal to 18 years at the time of signing the informed consent.
2. Diagnosed with T2D >=180 days before screening.
3. HbA1c >=8.0% (>=64.0 mmol/mol) as assessed by central laboratory on the day of screening.
4. Insulin naive. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
5. Currently treated with 1-3 OADs with stable daily doses >= 90 days before screening comprising any of the following anti-diabetic drug(s) at effective or maximum tolerated dosea
-Metformin
-Sulfonylureasb
-Meglitinides (glinides)
-DPP-4 inhibitorsb
-Sodium-glucose co-transporter 2 inhibitors
-Alpha-glucosidase-inhibitors
-Thiazolidinediones
-Marketed oral combination products only including the products listed above.6. Body mass index (BMI) <=40.0 kg/m2.

Exclude criteria

1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
3. Any episodesa of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
4. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
5. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
6. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
7. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
8. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within the past 90 days before 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: takizaki Hiroshi
• Secondary ID(s): NCT06269107