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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582448
• Other study ID #: NN1436-4572
• Secondary ID: U1111-1244-44952
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose	From 0 hours until infinity after trial product administration (pmol*h/L)	Day 1
Secondary	Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose	From 0 hours until infinity after trial product administration (pmol/L)	Day 1
Secondary	tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose	From 0 hours until infinity after trial product administration (hours)	Day 1