A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Icodec

Study type: Interventional

Funder types: Industry

Identifiers

NCT04582435

U1111-1244-4346 (Other Identifier)

2019-004606-10 (Registry Identifier)

NN1436-4569

Details and patient eligibility

About

The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.

Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.

Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.

The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Aged 18-75 years (both inclusive) at the time of signing informed consent
• Body mass index between 18.0 and 38.0 kg/m^2 (both inclusive)
• HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
• Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
• Oral or injectable GLP-1 Receptor Agonists

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Insulin icodec

Experimental group

Description:

Participants will receive individualised weekly doses of insulin icodec

Treatment:

Drug: Insulin Icodec