Diabetes Mellitus, Type 2Phase 1NCT04857398
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes
A Phase 1 study testing insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial summary
This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes. Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. Read more about this study
- Who is it for?
- Ages 18 to 64 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2021to 6 Apr 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 18 and 38 kg/m^2 (both inclusive)
- HbA1c (glycated haemoglobin) below or equal to 9% at screening
- Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 60 days prior to the day of screening:
- Any metformin formulation
- Other oral antidiabetic drugs: DPP-4 (Dipeptidyl-peptidase-4) Inhibitors , SGLT2 (Sodium-glucose co-transporter-2) inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs)
- Oral or injectable GLP-1 (Glucagon Like Peptide 1) Receptor Agonists
Who cannot join
- 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).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and run-in. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
Trial locations and contacts
1 site in 1 country.
China1 site
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853
About this study
Official title: A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Chinese Subjects With Type 2 Diabetes
This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes.
Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec.
Read more
The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period.
Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec.
Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study.
Women: Women cannot take part if pregnant, breast-feeding or plan 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
Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin.
The study will last for 15 to 22 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Insulin icodec | Experimental | The participants will receive an individualised weekly dose of subcutaneously (s.c.) insulin icodec for 6 weeks Receives: Drug: insulin icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state
pmol*h/L
Measured: From 0 to 168 hours after trial product administration (Day 36)
Secondary outcomes (5)
Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose
(pmol*h/L)/(U/kg)
Measured: From 0 to 168 hours after trial product administration (Day 36)
Maximum observed serum insulin icodec concentration after the last dose
pmol/L
Measured: From 0 to 168 hours after trial product administration (Day 36)
Maximum observed serum insulin icodec concentration after the last dose divided by dose
(pmol/L)/(U/kg)
Measured: From 0 to 168 hours after trial product administration (Day 36)
Time to maximum observed serum insulin icodec concentration after the last dose
hours
Measured: From 0 to 168 hours after trial product administration (Day 36)
Terminal half-life for insulin icodec at steady state
hours
Measured: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start28 Apr 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04857398
- Sponsor's protocol ID
- NN1436-4571
- Other IDs
- U1111-1244-4473
- Status last verified
- May 2023
- First submitted
- 22 Apr 2021
- Last updated
- 17 May 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. 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 Chinese Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04857398
- Acronym / sponsor ID
- NN1436-4571
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 23 Apr 2021 (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.
This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes.
Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec.
The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period.
Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec.
Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study.
Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin icodec | Experimental | Drug: insulin icodecThe participants will receive an individualised weekly dose of subcutaneously (s.c.) insulin icodec for 6 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Chinese male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 18 and 38 kg/m^2 (both inclusive)
- HbA1c (glycated haemoglobin) below or equal to 9% at screening
- Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 60 days prior to the day of screening:
Key exclusion criteria (4 listed)
- 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).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and run-in. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
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 icodecParticipants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin. The study will last for 15 to 22 weeks. | Drug | Insulin icodec |
Primary outcome
Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state
Time frame: From 0 to 168 hours after trial product administration (Day 36)
pmol*h/L
5 secondary outcomes
Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose
Time frame: From 0 to 168 hours after trial product administration (Day 36)
Maximum observed serum insulin icodec concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (Day 36)
Maximum observed serum insulin icodec concentration after the last dose divided by dose
Time frame: From 0 to 168 hours after trial product administration (Day 36)
Time to maximum observed serum insulin icodec concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (Day 36)
Terminal half-life for insulin icodec at steady state
Time frame: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 36)
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 17 May 2023.
- 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
1 site in 1 country: 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 1 site in China.
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 8 inclusion and 4 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (time frame: From 0 to 168 hours after trial product administration (Day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2023.