Diabetes Mellitus, Type 2Phase 1NCT04582448
A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People 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 Germany.
Trial summary
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions. Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. Read more about this study
- Who is it for?
- Ages 18 to 69 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
- 1 siteGermany
- Study dates
- 1 Oct 2020to 27 Sep 2021
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 18-69 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
- Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
- HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
- Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
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- Any metformin formulation
- Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
Read more
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
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
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
| Study group | Role | What they receive |
|---|---|---|
| Insulin icodec treatment sequence with injection region abdomen | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. Receives: Drug: Insulin icodec |
| Insulin icodec treatment sequence with injection region upper arm | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. Receives: Drug: Insulin icodec |
| Insulin icodec treatment sequence with injection region thigh | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. Receives: Drug: Insulin icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCIco,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 infinity 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 infinity 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 posted9 Oct 2020
- Study start1 Oct 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
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
- Randomised
- Intervention model
- Crossover
- 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
- NCT04582448
- Sponsor's protocol ID
- NN1436-4572
- Other IDs
- U1111-1244-4495, 2019-004660-21, 2019
- Status last verified
- Jan 2023
- First submitted
- 8 Oct 2020
- Last updated
- 20 Jan 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
Plum-Morschel L, Andersen LR, Hansen S, Hovelmann U, Krawietz P, Kristensen NR, Lehrskov LL, Haahr H. Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2023 Feb;43(2):119-127. doi: 10.1007/s40261-022-01243-6. Epub 2023 Jan 11.
PubMed 36631720
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 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 After Administration in Different Injection Regions in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04582448
- Acronym / sponsor ID
- NN1436-4572
- 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
- 1 Oct 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (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.
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin icodec treatment sequence with injection region abdomen | Experimental | Drug: Insulin icodecEach subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
| Insulin icodec treatment sequence with injection region upper arm | Experimental | Drug: Insulin icodecEach subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
| Insulin icodec treatment sequence with injection region thigh | Experimental | Drug: Insulin icodecEach subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Aged 18-69 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
- Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
- HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
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 (adequate contraceptive measures as required by local regulation or practice).
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 icodecA single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions. | Drug | Insulin icodec treatment sequence with injection region abdomen, Insulin icodec treatment sequence with injection region thigh, Insulin icodec treatment sequence with injection region upper arm |
Primary outcome
AUCIco,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 20 Jan 2023.
- Results publication: PubMed 36631720Plum-Morschel L, Andersen LR, Hansen S, Hovelmann U, Krawietz P, Kristensen NR, Lehrskov LL, Haahr H. Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2023 Feb;43(2):119-127. doi: 10.1007/s40261-022-01243-6. Epub 2023 Jan 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 Germany.
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 9 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 20 Jan 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 Germany. 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,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 NCT04582448, 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 20 Jan 2023.