Diabetes Mellitus, Type 2Phase 1NCT04597697
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin icodec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Dec 2020to 24 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin icodec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin icodecDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with normal hepatic function | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. Receives: Drug: Insulin icodec |
| Subjects with mild hepatic impairment, child-pugh grade A | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. Receives: Drug: Insulin icodec |
| Subjects with moderate hepatic impairment, child-pugh grade B | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. Receives: Drug: Insulin icodec |
| Subjects with severe hepatic impairment, child-pugh grade C | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. Receives: Drug: Insulin icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (2)
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)
Measured: Day 1
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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Dec 2020
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597697
- Sponsor's protocol ID
- NN1436-4570
- Status last verified
- Jul 2024
- First submitted
- 15 Oct 2020
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9.
PubMed 38722461
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT04597697
- Acronym / sponsor ID
- NN1436-4570
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with normal hepatic function | Experimental | Drug: Insulin icodecThe participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
| Subjects with mild hepatic impairment, child-pugh grade A | Experimental | Drug: Insulin icodecThe participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
| Subjects with moderate hepatic impairment, child-pugh grade B | Experimental | Drug: Insulin icodecThe participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
| Subjects with severe hepatic impairment, child-pugh grade C | Experimental | Drug: Insulin icodecThe participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin icodecInsulin 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. | Drug | Subjects with mild hepatic impairment, child-pugh grade A, Subjects with moderate hepatic impairment, child-pugh grade B, Subjects with normal hepatic function, Subjects with severe hepatic impairment, child-pugh grade C |
Primary outcome
AUC,Ico,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)
2 secondary outcomes
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
Time frame: Day 1
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Results publication: PubMed 38722461Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.