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

January 19, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
Time Frame: Day 1
From 0 hours until infinity after trial product administration (pmol*h/L)
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
Time Frame: Day 1
From 0 hours until infinity after trial product administration (pmol/L)
Day 1
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
Time Frame: Day 1
From 0 hours until infinity after trial product administration (hours)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 27, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4572
  • U1111-1244-4495 (Other Identifier: World Health Organization (WHO))
  • 2019-004660-21 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Insulin icodec

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe