Diabetes Mellitus, Type 1Phase 1NCT05262595
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
A Phase 1 study testing NNC0471-0119 A, NNC0471-0119 B and NNC0471-0119 D in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- NNC0471-0119 A, NNC0471-0119 B and NNC0471-0119 D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2022to 5 Sep 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with T1DM for more than1 year prior to the day of screening.
- Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
- Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.
Who cannot join
- Known or suspected hypersensitivity to study interventions or related products.
- Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of Three Formulations of NNC0471-0119 When Administered as One Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.
The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.
Read more
The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).
Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.
Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.
The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.
During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.
Women: Women cannot take part if they are of childbearing potential.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D, Faster aspart
- 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.
NNC0471-0119 ADrug
NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months
NNC0471-0119 BDrug
NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months
NNC0471-0119 DDrug
NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months
Faster aspartDrug
Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) Receives: Drug: NNC0471-0119 A |
| Arm 2 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) Receives: Drug: NNC0471-0119 B |
| Arm 3 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) Receives: Drug: NNC0471-0119 D |
| Arm 4 | Active comparator | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) Receives: Drug: Faster aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).
Measured in percentage
Measured: 0 to 12 hours after bolus infusion
Secondary outcomes (10)
AUC (NNC0471-0119,0-t,basal-corrected)
Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).
Measured in h*pmol/L
Measured: 0 to 12 hours after bolus infusion
AUC (NNC0471-0119,0-30min,basal-corrected)
Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes.
Measured in h*pmol/L
Measured: 0 to 30 minutes after bolus infusion
AUC (NNC0471-0119,2h-t,basal-corrected)
Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).
Measured in h*pmol/L
Measured: 2 to 12 hours after bolus infusion
AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).
Measured in percentage
Measured: 0 to 12 hours after bolus infusion
Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration
pmol/L
Measured: 0 to 12 hours after bolus infusion
Number of adverse events (AEs)
Number of events
Measured: From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6)
AUC (GIR,0-t,basal-corrected)
Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours).
Measured in mg/kg
Measured: 0 to 12 hours after bolus infusion
AUC (GIR,0-1h,basal-corrected)
Area under the basal-corrected GIR-time curve from 0 to 1 hour. Measured in mg/kg
Measured: 0 to 1 hour after bolus infusion
AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected)
Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours).
Measured in percentage
Measured: 0 to 12 hours after bolus infusion
GIRmax,basal-corrected: Maximum observed basal-corrected GIR
mg/(kg*min)
Measured: 0 to 12 hours after bolus infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start3 Mar 2022
- Primary completion29 Aug 2022
- Study completion5 Sep 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262595
- Sponsor's protocol ID
- NN1471-4752
- Other IDs
- U1111-1260-0359, 2020-005145-16
- Status last verified
- Oct 2023
- First submitted
- 21 Feb 2022
- Last updated
- 12 Oct 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of Three Formulations of NNC0471-0119 When Administered as One Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05262595
- Acronym / sponsor ID
- NN1471-4752
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 2 Mar 2022 (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 effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.
The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.
The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).
Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.
Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.
The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.
During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.
Women: Women cannot take part if they are of childbearing potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: NNC0471-0119 AA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 2 | Experimental | Drug: NNC0471-0119 BA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 3 | Experimental | Drug: NNC0471-0119 DA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 4 | Active comparator | Drug: Faster aspartA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with T1DM for more than1 year prior to the day of screening.
- Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
- Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to study interventions or related products.
- Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before 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 |
|---|---|---|
| NNC0471-0119 ANNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months | Drug | Arm 1 |
| NNC0471-0119 BNNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months | Drug | Arm 2 |
| NNC0471-0119 DNNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months | Drug | Arm 3 |
| Faster aspartFaster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months | Drug | Arm 4 |
Primary outcome
AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
Time frame: 0 to 12 hours after bolus infusion
Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage
10 secondary outcomes
AUC (NNC0471-0119,0-t,basal-corrected)
Time frame: 0 to 12 hours after bolus infusion
AUC (NNC0471-0119,0-30min,basal-corrected)
Time frame: 0 to 30 minutes after bolus infusion
AUC (NNC0471-0119,2h-t,basal-corrected)
Time frame: 2 to 12 hours after bolus infusion
AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
Time frame: 0 to 12 hours after bolus infusion
Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration
Time frame: 0 to 12 hours after bolus infusion
Number of adverse events (AEs)
Time frame: From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6)
AUC (GIR,0-t,basal-corrected)
Time frame: 0 to 12 hours after bolus infusion
AUC (GIR,0-1h,basal-corrected)
Time frame: 0 to 1 hour after bolus infusion
AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected)
Time frame: 0 to 12 hours after bolus infusion
GIRmax,basal-corrected: Maximum observed basal-corrected GIR
Time frame: 0 to 12 hours after bolus infusion
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 12 Oct 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. 2834) 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 NNC0471-0119 A, NNC0471-0119 B and NNC0471-0119 D in people with Diabetes Mellitus, Type 1, 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 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 12 Oct 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?
AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected) (time frame: 0 to 12 hours after bolus infusion). 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 12 Oct 2023.