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

NCT04582448 | Completed Phase 1

• 3 other identifiers: NN1436-4572U1111-1244-44952019-004660-21
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose

  Day 1

• tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose

  Day 1

Study Arms (3)

Insulin icodec treatment sequence with injection region abdomen

EXPERIMENTAL

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.

Drug: Insulin icodec

Insulin icodec treatment sequence with injection region upper arm

EXPERIMENTAL

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.

Drug: Insulin icodec

Insulin icodec treatment sequence with injection region thigh

EXPERIMENTAL

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.

Drug: Insulin icodec

Interventions

Insulin icodec 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 abdomen; Insulin icodec treatment sequence with injection region thigh; Insulin icodec treatment sequence with injection region upper arm

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

Related 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 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.

  PMID: 36631720 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 9, 2020
• Study Start: October 1, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)