DiabetesPhase 1NCT03407599
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
A Phase 1 study testing Faster aspart and Insulin aspart (NovoRapid®) in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. Read more about this study
- Who is it for?
- Ages 6 to 64 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Faster aspart and Insulin aspart (NovoRapid®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2018to 5 Jul 2018
- 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 6 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
- Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm
Who cannot join
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- Faster aspart, Insulin aspart (NovoRapid®)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster aspartDrug
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
Insulin aspart (NovoRapid®)Drug
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
| Study group | Role | What they receive |
|---|---|---|
| Faster aspart followed by insulin aspart (NovoRapid®) | Experimental | Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. Receives: Drug: Faster aspart; Drug: Insulin aspart (NovoRapid®) |
| Insulin aspart (NovoRapid®) followed by faster aspart | Experimental | Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. Receives: Drug: Faster aspart; Drug: Insulin aspart (NovoRapid®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Secondary outcomes (24)
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Calculated based on insulin aspart measured in blood.
Measured: 0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Calculated based on insulin aspart measured in blood.
Measured: 0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Calculated based on insulin aspart measured in blood.
Measured: 0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Calculated based on insulin aspart measured in blood.
Measured: 0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Calculated based on insulin aspart measured in blood.
Measured: 0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Measured: 0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Measured: Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Measured: Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Measured: 1 hour after administration
Plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Measured: 2 hours after administration
Maximum plasma glucose excursion after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-6 hours
Maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-6 hours
Time to maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-6 hours
Minimum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Measured: 0-6 hours
Number of adverse events
Count of events
Measured: From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes
Count of hypoglycaemic episodes
Measured: From screening day 1 up to the study completion day 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start8 Jan 2018
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 46 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
- NCT03407599
- Sponsor's protocol ID
- NN1218-4371
- Other IDs
- 2017-002014-31, U1111-1197-0428, 2017
- Status last verified
- Jun 2019
- First submitted
- 5 Jan 2018
- Last updated
- 19 Jun 2019
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03407599
- Acronym / sponsor ID
- NN1218-4371
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 23 Jan 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.
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.
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 |
|---|---|---|
| Faster aspart followed by insulin aspart (NovoRapid®) | Experimental | Drug: Faster aspart, Drug: Insulin aspart (NovoRapid®)Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. |
| Insulin aspart (NovoRapid®) followed by faster aspart | Experimental | Drug: Faster aspart, Drug: Insulin aspart (NovoRapid®)Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. |
Who may qualify
- Ages
- 6 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
- Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm
Key exclusion criteria (3 listed)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
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 aspartAn injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal. | Drug | Faster aspart followed by insulin aspart (NovoRapid®), Insulin aspart (NovoRapid®) followed by faster aspart |
| Insulin aspart (NovoRapid®)An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal. | Drug | Faster aspart followed by insulin aspart (NovoRapid®), Insulin aspart (NovoRapid®) followed by faster aspart |
Primary outcome
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Time frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
24 secondary outcomes
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Time frame: 0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Time frame: 0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Time frame: 0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Time frame: 0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Time frame: 0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration
Time frame: 0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Time frame: 0-12 hours
Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)
Time frame: 0-12 hours
Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve
Time frame: 0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Time frame: 0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Time frame: 0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration
Time frame: 0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration
Time frame: 0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration
Time frame: 0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration
Time frame: Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration
Time frame: Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration
Time frame: 1 hour after administration
Plasma glucose concentration 2 hours after administration
Time frame: 2 hours after administration
Maximum plasma glucose excursion after administration
Time frame: 0-6 hours
Maximum plasma glucose concentration after administration
Time frame: 0-6 hours
Time to maximum plasma glucose concentration after administration
Time frame: 0-6 hours
Minimum plasma glucose concentration after administration
Time frame: 0-6 hours
Number of adverse events
Time frame: From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes
Time frame: From screening day 1 up to the study completion day 68
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 19 Jun 2019.
- 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 and Insulin aspart (NovoRapid®) in people with Diabetes and 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 19 Jun 2019. 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(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours (time frame: 0-12 hours). 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 19 Jun 2019.