A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes

NCT ID: NCT04582448

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-09-27

Brief Summary

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.

Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.

The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin icodec treatment sequence with injection region abdomen

Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.

Insulin icodec treatment sequence with injection region upper arm

Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.

Insulin icodec treatment sequence with injection region thigh

Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.

Interventions

Insulin icodec

A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female
• Aged 18-69 years (both inclusive) at the time of signing informed consent
• Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
• Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
• HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
• Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
• Any metformin formulation
• Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
• Oral or injectable GLP-1 (glucagon-like peptide 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 (adequate contraceptive measures as required by local regulation or practice).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Mainz, , Germany

Countries

Germany

References

Plum-Morschel L, Andersen LR, Hansen S, Hovelmann U, Krawietz P, Kristensen NR, Lehrskov LL, Haahr H. Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2023 Feb;43(2):119-127. doi: 10.1007/s40261-022-01243-6. Epub 2023 Jan 11.

Reference Type: RESULT

PMID: 36631720 (View on PubMed)

Other Identifiers

U1111-1244-4495

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004660-21

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1436-4572

Identifier Type: -

Identifier Source: org_study_id