A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

Novo Nordisk

Status and phase: Not yet enrolling; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Basal insulin analogues; Drug: Insulin icodec

Study type: Interventional

Funder types: Industry

Identifiers

NCT07112339

U1111-1302-4943 (Other Identifier)

NN1436-7727

2024-520068-32 (Other Identifier)

Details and patient eligibility

About

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
• Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:

Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.

• Need of intensification with basal insulin, as indicated at the discretion of the investigator.
• Recorded HbA1c value ≥7% within the last 90 days prior to randomization.

Exclusion criteria

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous participation in this study. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
• Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
• Any disorder which in the investigator's opinion might jeopardize participant's safety.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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586 participants in 2 patient groups

Insulin icodec

Experimental group

Description:

Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.

Treatment:

Drug: Insulin icodec

Basal insulin analogues

Active Comparator group

Description:

Participants will receive once daily s.c. injection of basal insulin analogues.

Treatment:

Drug: Basal insulin analogues