Diabetes Mellitus, Type 2Phase 1NCT04582435
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects 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 Austria.
Trial summary
The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment. Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors. Read more about this study
- Who is it for?
- Any age
- 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
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 16 Oct 2020to 22 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female
- Aged 18-75 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.0 and 38.0 kg/m^2 (both inclusive)
- HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
- Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
- Oral or injectable GLP-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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.
Read more
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.
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 receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Insulin icodec | Experimental | Participants will receive individualised weekly doses of insulin icodec Receives: Drug: Insulin Icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCIco,τ,SS, 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 50)
Secondary outcomes (10)
AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Measured: From 0 to 36 hours after trial product administration (Day 36)
AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Measured: From 40 to 64 hours after trial product administration (Day 43)
AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Measured: From 144 to 168 hours after trial product administration (Day 50)
AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state
mg/kg
Measured: From 0 to 168 hours after trial product administration (Day 50)
AUCIco,τ,SS, 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 and 43)
Dose-normalised AUCIco,τ,SS, 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 50)
Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state
pmol/L
Measured: From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
Dose-normalised Cmax,Ico,SS, 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 50)
tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose
hours
Measured: From 0 to 168 hours after trial product administration (Day 50)
t½,Ico,SS, 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 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start16 Oct 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT04582435
- Sponsor's protocol ID
- NN1436-4569
- Other IDs
- U1111-1244-4346, 2019-004606-10, 2019
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2020
- Last updated
- 18 Sep 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
Publications
Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 11.
PubMed 37694740
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04582435
- Acronym / sponsor ID
- NN1436-4569
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 9 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.
The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.
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 IcodecParticipants will receive individualised weekly doses of insulin icodec |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Aged 18-75 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.0 and 38.0 kg/m^2 (both inclusive)
- HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
- Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
Key exclusion criteria (2 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
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 receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment. | Drug | Insulin icodec |
Primary outcome
AUCIco,τ,SS, 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 50)
pmol*h/L
10 secondary outcomes
AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state
Time frame: From 0 to 36 hours after trial product administration (Day 36)
AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state
Time frame: From 40 to 64 hours after trial product administration (Day 43)
AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state
Time frame: From 144 to 168 hours after trial product administration (Day 50)
AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state
Time frame: From 0 to 168 hours after trial product administration (Day 50)
AUCIco,τ,SS, 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 and 43)
Dose-normalised AUCIco,τ,SS, 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 50)
Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state
Time frame: From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
Dose-normalised Cmax,Ico,SS, 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 50)
tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (Day 50)
t½,Ico,SS, 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 50)
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 18 Sep 2023.
- Background: PubMed 37694740Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 11.
- 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 Austria.
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 6 inclusion and 2 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 18 Sep 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 Austria. 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?
AUCIco,τ,SS, 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 50)). 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 NCT04582435, 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 18 Sep 2023.