Diabetes Mellitus, Type 1Phase 1NCT03723772
A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
A Phase 1 study testing Insulin icodec and IGlar U100 in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin icodec and IGlar U100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 29 Nov 2018to 26 Jun 2020
- 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
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
- Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
- Body mass index between 18.5 and 29.0 kg/m^2 (both inclusive)
- HbA1c less than or equal to 9.0%
Who cannot join
- History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- Known or suspected hypersensitivity to trial products or related products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes
This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin icodec, IGlar U100
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin icodecDrug
Also called Insulin 287
Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
IGlar U100Drug
Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Insulin 287 followed by insulin glargine U100 | Experimental | Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.
After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine.
After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks. Receives: Drug: Insulin icodec; Drug: IGlar U100 |
| Insulin glargine U100 followed by insulin 287 | Experimental | Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.
After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment.
After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling. Receives: Drug: Insulin icodec; Drug: IGlar U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
Measured in pmol*h/L
Measured: From 0 to 168 hours after trial product administration (Day 50)
Secondary outcomes (22)
AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
Measured: From 16 to 52 hours after trial product administration (Day 50)
AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
Measured: From 138 to 168 hours after trial product administration (Day 50)
GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
Measured: From 16 to 52 hours after trial product administration (Day 50)
GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
Measured: From 138 to 168 hours after trial product administration (Day 50)
AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
Measured: From 0 to 24 hours after trial product administration (Day 14)
GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
Measured: From 0 to 24 hours after trial product administration (Day 14)
AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose
Measured in pmol*h/L
Measured: From 0 to 168 hours after trial product administration (Day 1)
Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose
Measured in pmol/L
Measured: From 0 to 168 hours after trial product administration (Day 1)
tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose
Measured in hours
Measured: From 0 to 168 hours after trial product administration (Day 1)
Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose
Measured in pmol/L
Measured: From 0 to 168 hours after trial product administration (Day 50)
tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose
Measured in hours
Measured: From 0 to 168 hours after trial product administration (Day 50)
t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state
Measured in hours
Measured: Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
CI287,trough (for insulin 287) - Serum insulin 287 trough concentration
Measured in pmol/L
Measured: Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)
AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state
Measured in pmol*h/L
Measured: From 0 to 24 hours after trial product administration (Day 14)
Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state
Measured in pmol/L
Measured: From 0 to 24 hours after trial product administration (Day 14)
tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state
Measured in hours
Measured: From 0 to 24 hours after trial product administration (Day 14)
CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration
Measured in pmol/L
Measured: Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)
Number of adverse events (AEs)
Number of events
Measured: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Number of hypoglycaemic episodes
Number of episodes
Measured: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Change in anti-insulin 287 antibody level
Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
Measured: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Change in anti-insulin 287 antibody titres
Number of dilutions
Measured: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Positive cross-reactive anti-human insulin antibodies
Number of patients with/without positive cross-reactive anti-human insulin antibodies
Measured: At the follow-up visit (Visit 25, day 106)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start29 Nov 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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 1Studies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723772
- Sponsor's protocol ID
- NN1436-4225
- Other IDs
- U1111-1204-8909, 2017-004528-31, 2017
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2018
- Last updated
- 11 Mar 2025
- 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
Hovelmann U, Engberg S, Heise T, Kristensen NR, Norgreen L, Zijlstra E, Ribel-Madsen R. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 1 diabetes. Diabetes Obes Metab. 2024 May;26(5):1941-1949. doi: 10.1111/dom.15510. Epub 2024 Feb 20.
PubMed 38379002
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03723772
- Acronym / sponsor ID
- NN1436-4225
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 30 Oct 2018 (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 compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin 287 followed by insulin glargine U100 | Experimental | Drug: Insulin icodec, Drug: IGlar U100Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks. |
| Insulin glargine U100 followed by insulin 287 | Experimental | Drug: Insulin icodec, Drug: IGlar U100Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment. After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
- Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
- Body mass index between 18.5 and 29.0 kg/m^2 (both inclusive)
- HbA1c less than or equal to 9.0%
Key exclusion criteria (2 listed)
- History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- Known or suspected hypersensitivity to trial products or related products
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 icodecAlso: Insulin 287Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks | Drug | Insulin 287 followed by insulin glargine U100, Insulin glargine U100 followed by insulin 287 |
| IGlar U100Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks. | Drug | Insulin 287 followed by insulin glargine U100, Insulin glargine U100 followed by insulin 287 |
Primary outcome
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
Time frame: From 0 to 168 hours after trial product administration (Day 50)
Measured in pmol*h/L
22 secondary outcomes
AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Time frame: From 16 to 52 hours after trial product administration (Day 50)
AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Time frame: From 138 to 168 hours after trial product administration (Day 50)
GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Time frame: From 16 to 52 hours after trial product administration (Day 50)
GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Time frame: From 138 to 168 hours after trial product administration (Day 50)
AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state
Time frame: From 0 to 24 hours after trial product administration (Day 14)
GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state
Time frame: From 0 to 24 hours after trial product administration (Day 14)
AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose
Time frame: From 0 to 168 hours after trial product administration (Day 1)
Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose
Time frame: From 0 to 168 hours after trial product administration (Day 1)
tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose
Time frame: From 0 to 168 hours after trial product administration (Day 1)
Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (Day 50)
tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (Day 50)
t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state
Time frame: Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
CI287,trough (for insulin 287) - Serum insulin 287 trough concentration
Time frame: Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)
AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state
Time frame: From 0 to 24 hours after trial product administration (Day 14)
Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state
Time frame: From 0 to 24 hours after trial product administration (Day 14)
tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state
Time frame: From 0 to 24 hours after trial product administration (Day 14)
CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration
Time frame: Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)
Number of adverse events (AEs)
Time frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Number of hypoglycaemic episodes
Time frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Change in anti-insulin 287 antibody level
Time frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Change in anti-insulin 287 antibody titres
Time frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Positive cross-reactive anti-human insulin antibodies
Time frame: At the follow-up visit (Visit 25, day 106)
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 11 Mar 2025.
- Results publication: PubMed 38379002Hovelmann U, Engberg S, Heise T, Kristensen NR, Norgreen L, Zijlstra E, Ribel-Madsen R. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 1 diabetes. Diabetes Obes Metab. 2024 May;26(5):1941-1949. doi: 10.1111/dom.15510. Epub 2024 Feb 20.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Reporting Anchor and Disclosure (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 and IGlar U100 in people with Diabetes Mellitus, Type 1, 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 5 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 11 Mar 2025. 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?
AUCI287,τ,SS - Area under the serum insulin 287 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 NCT03723772, 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 11 Mar 2025.