Diabetes Mellitus, Type 1Phase 1NCT03766854
A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week
A Phase 1 study testing insulin icodec and Insulin glargine U100 in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin icodec and Insulin glargine U100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 7 Dec 2018to 9 Dec 2019
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, Japanese subjects, aged 20 - 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 28.0 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 (except conditions associated with diabetes mellitus).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
- 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 Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes
This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants 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 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- insulin icodec, Insulin glargine 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 (s.c.) injections of insulin 287 once weekly for 8 weeks
Insulin glargine U100Drug
Participants will receive s.c. 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 7 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 (PK) 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: Insulin glargine U100 |
| Insulin glargine U100 followed by insulin 287 | Experimental | Run-in period (2 days to 7 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 OW for 8 weeks and subsequent 4 weeks of terminal PK sampling. Receives: Drug: insulin icodec; Drug: Insulin glargine U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCI287τ,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)
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) excluding clamp days
Change in antiinsulin 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 (day 106)
Change in antiinsulin 287 antibody titres
Number of dilutions.
The antibody titer is calculated by diluting the blood serum sample containing antibody in serial ratios (1:2, 1:4, 1:8, 1:16... and so on). Using an appropriate detection method (e.g., colorimetric, chromatographic, etc.), each dilution is tested for the presence of detectable levels of antibody. The assigned titer value is indicative of the last dilution in which the antibody was detected.
Measured: From first insulin 287 administration (day 1) to follow-up visit (day 106)
Positive cross-reactive anti-human insulin antibodies
Yes/no. Number of participants who developed/not developed positive cross-reactive anti-human insulin antibodies.
Measured: At follow-up visit (day 106)
AUCI287,0-168,FD - 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)
tmax,I287,FD - 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,FD - 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,SS - 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)
Cmax,I287,SS - 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)
t1/2,I287,SS - 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 - Serum insulin 287 trough concentration
Measured in pmol/L
Measured: Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)
AUCIGlar,τ,SS - Area under the serum IGlar 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 - Maximum observed serum IGlar concentration at steady state
Measured in pmol/L
Measured: From 0 to 24 hours after trial product administration (day 14)
tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state
Measured in hours
Measured: From 0 to 24 hours from trial product administration (day 14)
CIGlar,trough - Serum IGlar trough concentration
Measured in pmol/L
Measured: Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)
AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
Measured: From 24 to 48 hours after trial product administration (day 51)
GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
Measured: From 24 to 48 hours after trial product administration (day 51)
AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
Measured: From 150 to 168 hours after trial product administration (day 57)
GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
Measured: From 150 to 168 hours after trial product administration (day 57)
AUCGIR,0-24h,SS - 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 - 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start7 Dec 2018
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 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
- NCT03766854
- Sponsor's protocol ID
- NN1436-4422
- Other IDs
- U1111-1211-7635
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2018
- Last updated
- 8 Mar 2021
- 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 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03766854
- Acronym / sponsor ID
- NN1436-4422
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 6 Dec 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 will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants 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 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.
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: Insulin glargine U100Run-in period (2 days to 7 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 (PK) 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: Insulin glargine U100Run-in period (2 days to 7 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 OW for 8 weeks and subsequent 4 weeks of terminal PK sampling. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, Japanese subjects, aged 20 - 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 28.0 kg/m^2 (both inclusive).
- HbA1c less than or equal to 9.0%.
Key exclusion criteria (3 listed)
- History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
- 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 (s.c.) injections of insulin 287 once weekly for 8 weeks | Drug | Insulin 287 followed by insulin glargine U100, Insulin glargine U100 followed by insulin 287 |
| Insulin glargine U100Participants will receive s.c. 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
AUCI287τ,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
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) excluding clamp days
Change in antiinsulin 287 antibody level
Time frame: From first insulin 287 administration (day 1) to follow-up visit (day 106)
Change in antiinsulin 287 antibody titres
Time frame: From first insulin 287 administration (day 1) to follow-up visit (day 106)
Positive cross-reactive anti-human insulin antibodies
Time frame: At follow-up visit (day 106)
AUCI287,0-168,FD - 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)
tmax,I287,FD - 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,FD - 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,SS - 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)
Cmax,I287,SS - Maximum observed serum insulin 287 concentration after the last dose
Time frame: From 0 to 168 hours after trial product administration (day 50)
t1/2,I287,SS - 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 - Serum insulin 287 trough concentration
Time frame: Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)
AUCIGlar,τ,SS - Area under the serum IGlar 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 - Maximum observed serum IGlar concentration at steady state
Time frame: From 0 to 24 hours after trial product administration (day 14)
tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state
Time frame: From 0 to 24 hours from trial product administration (day 14)
CIGlar,trough - Serum IGlar trough concentration
Time frame: Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)
AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state
Time frame: From 24 to 48 hours after trial product administration (day 51)
GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state
Time frame: From 24 to 48 hours after trial product administration (day 51)
AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state
Time frame: From 150 to 168 hours after trial product administration (day 57)
GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state
Time frame: From 150 to 168 hours after trial product administration (day 57)
AUCGIR,0-24h,SS - 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 - Maximum observed glucose infusion rate at steady state
Time frame: From 0 to 24 hours after trial product administration (day 14)
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 8 Mar 2021.
- 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 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 Insulin glargine U100 in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
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 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 8 Mar 2021. 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 Japan. 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?
AUCI287τ,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?
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 8 Mar 2021.