Diabetes Mellitus, Type 1Phase 1NCT03723759

A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus

A Phase 1 study testing Faster Aspart 200 U/mL and Faster aspart 100 U/mL in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Faster Aspart 200 U/mL and Faster aspart 100 U/mL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteGermany
Study dates: 26 Oct 2018to 27 Mar 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 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
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening

Who cannot join

Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial
Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening
Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods

Trial locations and contacts

1 site in 1 country.

Germany1 site

Novo Nordisk Investigational Site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus

This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).

Conditions: Diabetes Mellitus, Type 1
Being tested: Faster Aspart 200 U/mL, Faster aspart 100 U/mL
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.

Faster Aspart 200 U/mLDrug
A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
Faster aspart 100 U/mLDrug
A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.

Study groups in NCT03723759
Study group	Role	What they receive
Group A	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL
Group B	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL
Group C	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL
Group D	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL
Group E	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL
Group F	Experimental	Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days). Receives: Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
Measured in pmol*h/L
Measured: 0 to 10 hours after IMP administration

Secondary outcomes (8)

AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
Measured in pmol*h/L
Measured: 0 to 1 hour after IMP administration
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
Measured in pmol*h/L
Measured: 0 to 2 hours after IMP administration
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
Measured in pmol*h/L
Measured: 0 to 10 hours after IMP administration
Cmax,IAsp - Maximum observed serum insulin aspart concentration
Measured in pmol/L
Measured: 0 to 10 hours after IMP administration
tmax,IAsp - Time to maximum observed serum insulin aspart concentration
Measured in minutes
Measured: 0 to 10 hours after IMP administration
Number of adverse events in the treatment emergent period
Count of events
Measured: 0 to 2 days after IMP administration
Number of local reactions at the injection site in the treatment emergent period
Count of injection site reactions
Measured: 0 to 2 days after IMP administration
Number of hypoglycaemic episodes in the treatment emergent period
Count of hypoglycaemic episodes
Measured: 0 to 16 hours after IMP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 201827 Mar 2019

First posted30 Oct 2018
Study start26 Oct 2018
Primary completion21 Mar 2019
Study completion27 Mar 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03723759
Sponsor's protocol ID: NN1200-4431
Other IDs: U1111-1209-2099, 2018-000593-30, 2018
Status last verified: Mar 2020
First submitted: 26 Oct 2018
Last updated: 18 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03723759
Acronym / sponsor ID: NN1200-4431
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 26 Oct 2018 (actual)
Primary completion: 21 Mar 2019 (actual)
Study completion: 27 Mar 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group A	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days).
Group B	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days).
Group C	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days).
Group D	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days).
Group E	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days).
Group F	Experimental	Drug: Faster Aspart 200 U/mL, Drug: Faster aspart 100 U/mLParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days).

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 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
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening

Key exclusion criteria (3 listed)

Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial
Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening
Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods

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
Faster Aspart 200 U/mLA single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.	Drug	Group A, Group B, Group C, Group D, Group E, Group F
Faster aspart 100 U/mLA single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.	Drug	Group A, Group B, Group C, Group D, Group E, Group F

Primary outcome

AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
Time frame: 0 to 10 hours after IMP administration
Measured in pmol*h/L

8 secondary outcomes

AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
Time frame: 0 to 1 hour after IMP administration
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
Time frame: 0 to 2 hours after IMP administration
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
Time frame: 0 to 10 hours after IMP administration
Cmax,IAsp - Maximum observed serum insulin aspart concentration
Time frame: 0 to 10 hours after IMP administration
tmax,IAsp - Time to maximum observed serum insulin aspart concentration
Time frame: 0 to 10 hours after IMP administration
Number of adverse events in the treatment emergent period
Time frame: 0 to 2 days after IMP administration
Number of local reactions at the injection site in the treatment emergent period
Time frame: 0 to 2 days after IMP administration
Number of hypoglycaemic episodes in the treatment emergent period
Time frame: 0 to 16 hours after IMP administration

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 18 Mar 2020.
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 Faster Aspart 200 U/mL and Faster aspart 100 U/mL 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 3 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 18 Mar 2020. 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?

AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure (time frame: 0 to 10 hours after IMP administration). 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 NCT03723759.

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 18 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.