Diabetes Mellitus, Type 2Phase 1NCT07068295
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump
A Phase 1 study testing NNC0471-0119 H and Insulin Aspart in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. 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?
- NNC0471-0119 H and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jul 2025to 10 Mar 2026
- 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 (sex at birth).
- Age 18-69 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.
- Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day [(I) U/kg/day] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
- Any metformin formulation
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- Dipeptidyl peptidase-4 inhibitor (DPP4i)
- Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
- Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
- HbA1c lesser than or equal to (≤) 9.5%
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
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 NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 2 Diabetes
This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0471-0119 H, Insulin Aspart
- 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.
NNC0471-0119 HDrug
NNC0471-0119 H will be administered subcutaneously.
Insulin AspartDrug
Insulin aspart will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0471-0119 H then Insulin Aspart | Experimental | Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2. Receives: Drug: NNC0471-0119 H; Drug: Insulin Aspart |
| Insulin Aspart then NNC0471-0119 H | Active comparator | Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2. Receives: Drug: NNC0471-0119 H; Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
Measured in milligram per kilogram (mg/kg).
Measured: 0 to 1 hour after bolus infusion
Secondary outcomes (12)
AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t
Measured in mg/kg.
Measured: 0 to 11 hours 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
Measured in percentage (%).
Measured: 0 to 11 hours after bolus infusion
GIR (max,basal-corrected): Maximum observed basal-corrected GIR
Measured in milligrams per (kilogram *minute) (mg/[kg*min]).
Measured: 0 to 11 hours after bolus infusion
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
Measured in %.
Measured: 0 to 11 hours after bolus infusion
AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t
Measured in hours*picomole per liter (h*pmol/L).
Measured: 0 to 11 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
Measured in h*pmol/L.
Measured: 2 to 11 hours after bolus infusion
AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,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
Measured in %.
Measured: 0 to 11 hours after bolus infusion
C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in picomoles per litre (pmol/L).
Measured: 0 to 11 hours after bolus infusion
t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in minutes (Min).
Measured: 0 to 11 hours after bolus infusion
t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in min.
Measured: 0 to 11 hours after bolus infusion
Number of adverse events (AEs)
Measure in number of events.
Measured: From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start11 Jul 2025
- Primary completion22 Feb 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 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
- NCT07068295
- Sponsor's protocol ID
- NN1471-5026
- Other IDs
- U1111-1283-0507, 2024-520230-29
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2025
- Last updated
- 7 Apr 2026
- 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 7 Apr 2026. 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 NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07068295
- Acronym / sponsor ID
- NN1471-5026
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 22 Feb 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 16 Jul 2025 (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 looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0471-0119 H then Insulin Aspart | Experimental | Drug: NNC0471-0119 H, Drug: Insulin AspartParticipants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2. |
| Insulin Aspart then NNC0471-0119 H | Active comparator | Drug: NNC0471-0119 H, Drug: Insulin AspartParticipants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female (sex at birth).
- Age 18-69 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.
- Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day [(I) U/kg/day] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
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 HNNC0471-0119 H will be administered subcutaneously. | Drug | Insulin Aspart then NNC0471-0119 H, NNC0471-0119 H then Insulin Aspart |
| Insulin AspartInsulin aspart will be administered subcutaneously. | Drug | Insulin Aspart then NNC0471-0119 H, NNC0471-0119 H then Insulin Aspart |
Primary outcome
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
Time frame: 0 to 1 hour after bolus infusion
Measured in milligram per kilogram (mg/kg).
12 secondary outcomes
AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t
Time frame: 0 to 11 hours 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
Time frame: 0 to 11 hours after bolus infusion
GIR (max,basal-corrected): Maximum observed basal-corrected GIR
Time frame: 0 to 11 hours after bolus infusion
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
Time frame: 0 to 11 hours after bolus infusion
AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t
Time frame: 0 to 11 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
Time frame: 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
Time frame: 2 to 11 hours after bolus infusion
AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,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
Time frame: 0 to 11 hours after bolus infusion
C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration
Time frame: 0 to 11 hours after bolus infusion
t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Time frame: 0 to 11 hours after bolus infusion
t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Time frame: 0 to 11 hours after bolus infusion
Number of adverse events (AEs)
Time frame: From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days)
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 7 Apr 2026.
- 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 H and Insulin Aspart 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 10 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 7 Apr 2026. 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?
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour (time frame: 0 to 1 hour 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 7 Apr 2026.