DiabetesPhase 1NCT02304627
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
A Phase 1 study testing insulin 338 (GIPET I) in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- What is being tested?
- insulin 338 (GIPET I)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2014to 31 Jul 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as informed consent
- Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.
- Being tested
- insulin 338 (GIPET I)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin 338 (GIPET I)Drug
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
| Study group | Role | What they receive |
|---|---|---|
| Eating meal immediately after dosing | Experimental | Not described Receives: Drug: insulin 338 (GIPET I) |
| Eating meal 30 min after dosing | Experimental | Not described Receives: Drug: insulin 338 (GIPET I) |
| Eating meal 1 hour after dosing | Experimental | Not described Receives: Drug: insulin 338 (GIPET I) |
| Eating meal 6 hour after dosing | Experimental | Not described Receives: Drug: insulin 338 (GIPET I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin 338 concentration-time curve
Measured: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points
Secondary outcomes (4)
Area under the serum insulin 338 concentration-time curve
Measured: From 0 to 288 hours after a single dose (SD)
Maximum observed serum insulin 338 concentration
Measured: From 0 to 288 hours after a single dose (SD)
Area under the plasma capric acid concentration-time curve
Measured: From 0 to 24 hours after a single dose
Maximum observed plasma capric acid concentration
Measured: From 0 to 24 hours after a single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start24 Nov 2014
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304627
- Sponsor's protocol ID
- NN1953-3974
- Other IDs
- 2014-000979-87, U1111-1154-0535, 2014
- Status last verified
- Jul 2019
- First submitted
- 21 Nov 2014
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2.
PubMed 31093929
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02304627
- Acronym / sponsor ID
- NN1953-3974
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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 trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eating meal immediately after dosing | Experimental | Drug: insulin 338 (GIPET I) |
| Eating meal 30 min after dosing | Experimental | Drug: insulin 338 (GIPET I) |
| Eating meal 1 hour after dosing | Experimental | Drug: insulin 338 (GIPET I) |
| Eating meal 6 hour after dosing | Experimental | Drug: insulin 338 (GIPET I) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as informed consent
- Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
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 338 (GIPET I)Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods. | Drug | Eating meal 1 hour after dosing, Eating meal 30 min after dosing, Eating meal 6 hour after dosing, Eating meal immediately after dosing |
Primary outcome
Area under the serum insulin 338 concentration-time curve
Time frame: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points
4 secondary outcomes
Area under the serum insulin 338 concentration-time curve
Time frame: From 0 to 288 hours after a single dose (SD)
Maximum observed serum insulin 338 concentration
Time frame: From 0 to 288 hours after a single dose (SD)
Area under the plasma capric acid concentration-time curve
Time frame: From 0 to 24 hours after a single dose
Maximum observed plasma capric acid concentration
Time frame: From 0 to 24 hours after a single dose
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 Jul 2019.
- Results publication: PubMed 31093929Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 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 338 (GIPET I) in people with Diabetes and Healthy, 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 8 Jul 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?
Area under the serum insulin 338 concentration-time curve (time frame: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points). 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 NCT02304627, which also lists 1 linked publication.
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 Jul 2019.