Back to resultsA Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Insulin icodec
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Aged 18-70 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.5 and 39.9 kg/m^2 (both inclusive) Specific inclusion criterion only for subjects with hepatic impairment
- Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product 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)
- Diagnosis of diabetes mellitus
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Subjects with normal hepatic function
Subjects with mild hepatic impairment, child-pugh grade A
Subjects with moderate hepatic impairment, child-pugh grade B
Subjects with severe hepatic impairment, child-pugh grade C
Arm Description
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Outcomes
Primary Outcome Measures
AUC,Ico,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)
Secondary Outcome Measures
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
From 0 hours until last measurement time after trial product administration (pmol/L)
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
From 0 hours until last measurement time after trial product administration (hours)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04597697
Brief Title
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Official Title
A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing.
The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit.
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 mL (about a spoonful).
Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ).
Women cannot take part if 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with normal hepatic function
Arm Type
Experimental
Arm Description
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Arm Title
Subjects with mild hepatic impairment, child-pugh grade A
Arm Type
Experimental
Arm Description
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Arm Title
Subjects with moderate hepatic impairment, child-pugh grade B
Arm Type
Experimental
Arm Description
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Arm Title
Subjects with severe hepatic impairment, child-pugh grade C
Arm Type
Experimental
Arm Description
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Intervention Description
Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
Primary Outcome Measure Information:
Title
AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
Description
From 0 hours until infinity after trial product administration (pmol*h/L)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
Description
From 0 hours until last measurement time after trial product administration (pmol/L)
Time Frame
Day 1
Title
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
Description
From 0 hours until last measurement time after trial product administration (hours)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female
Aged 18-70 years (both inclusive) at the time of signing informed consent
Body mass index between 18.5 and 39.9 kg/m^2 (both inclusive) Specific inclusion criterion only for subjects with hepatic impairment
Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion Criteria:
Known or suspected hypersensitivity to trial product 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)
Diagnosis of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Praha 7
ZIP/Postal Code
17000
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia
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 a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
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