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A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin icodec
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female Aged 10 to less than (<) 18 years at the time of signing informed consent Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 30 days prior to the day of screening Glycated haemoglobin (HbA1c) less than or equal to (<=) 10% (86 millimoles per mole [mmol/mol]) at screening Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s). Current daily basal insulin treatment >= 0.2 (I) units per kilogram per day (U/kg/day) with stable doses >=30 days prior to the day of screening Exclusion Criteria: Known or suspected hypersensitivity to study interventions or related products Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Type 2 Diabetes

Arm Description

Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing.

Outcomes

Primary Outcome Measures

Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
Measured in picomoles*hours per liter (pmol*h/L).
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Measured in picomoles per liter (pmol/L).
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Measured in hours.

Secondary Outcome Measures

Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
Measured in pmol/L.
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Measured in pmol*h/L.

Full Information

First Posted
March 17, 2023
Last Updated
September 19, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05790681
Brief Title
A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
Official Title
A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
January 21, 2026 (Anticipated)
Study Completion Date
January 21, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. The study will last for about 8 weeks. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 milliliter (mL) (a little less than a quarter of a teaspoonful). The amount of insulin icodec participant will receive depends on participant's body weight. Participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Type 2 Diabetes
Arm Type
Experimental
Arm Description
Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing.
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Intervention Description
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
Primary Outcome Measure Information:
Title
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
Description
Measured in picomoles*hours per liter (pmol*h/L).
Time Frame
From 0 hours until infinity after trial product administration (day 1)
Title
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Description
Measured in picomoles per liter (pmol/L).
Time Frame
From 0 hours until last measurement time after trial product administration (day 1)
Title
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Description
Measured in hours.
Time Frame
From 0 hours until last measurement time after trial product administration (day 1)
Secondary Outcome Measure Information:
Title
Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
Description
Measured in pmol/L.
Time Frame
From 0 to 168 hours after trial product administration
Title
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Description
Measured in pmol*h/L.
Time Frame
From 0 to 168 hours after trial product administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Aged 10 to less than (<) 18 years at the time of signing informed consent Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 30 days prior to the day of screening Glycated haemoglobin (HbA1c) less than or equal to (<=) 10% (86 millimoles per mole [mmol/mol]) at screening Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s). Current daily basal insulin treatment >= 0.2 (I) units per kilogram per day (U/kg/day) with stable doses >=30 days prior to the day of screening Exclusion Criteria: Known or suspected hypersensitivity to study interventions or related products Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers

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