DiabetesPhase 1NCT01865331
Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects
A Phase 1 study testing insulin degludec and insulin degludec/insulin aspart 50 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 this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- What is being tested?
- insulin degludec and insulin degludec/insulin aspart 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Mar 2007
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese passport holder
- Japanese-born parents
- Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Fasting blood glucose of below or equal to 6 mmol/L
- Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator
Who cannot join
- The receipt of any investigational drug within 3 months prior to this trial
- Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.
- Being tested
- insulin degludec, placebo, insulin degludec/insulin aspart 50
- 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 degludecDrug
Single dose administered subcutaneously (s.c., under the skin).
placeboDrug
Administered subcutaneously (s.c., under the skin)
insulin degludec/insulin aspart 50Drug
Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Low dose, insulin degludec | Experimental | Not described Receives: Drug: insulin degludec; Drug: placebo |
| Medium dose, insulin degludec | Experimental | Not described Receives: Drug: insulin degludec; Drug: placebo |
| High dose, insulin degludec | Experimental | Not described Receives: Drug: insulin degludec; Drug: placebo |
| IDegAsp 50 | Experimental | Not described Receives: Drug: placebo; Drug: insulin degludec/insulin aspart 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs)
Measured: From dosing visit and until follow-up 7-21 days after last dosing visit
Secondary outcomes (2)
Area under the serum insulin concentration curve
Measured: 0-96 hours after dosing
Area under the glucose infusion rate curve
Measured: 0-24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startDec 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01865331
- Sponsor's protocol ID
- NN5401-1788
- Other IDs
- 2006-002615-26
- Status last verified
- Jan 2016
- First submitted
- 27 May 2013
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT01865331
- Acronym / sponsor ID
- NN5401-1788
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 30 May 2013 (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 this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose, insulin degludec | Experimental | Drug: insulin degludec, Drug: placebo |
| Medium dose, insulin degludec | Experimental | Drug: insulin degludec, Drug: placebo |
| High dose, insulin degludec | Experimental | Drug: insulin degludec, Drug: placebo |
| IDegAsp 50 | Experimental | Drug: placebo, Drug: insulin degludec/insulin aspart 50 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese passport holder
- Japanese-born parents
- Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Fasting blood glucose of below or equal to 6 mmol/L
- Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator
Key exclusion criteria (2 listed)
- The receipt of any investigational drug within 3 months prior to this trial
- Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, 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 degludecSingle dose administered subcutaneously (s.c., under the skin). | Drug | High dose, insulin degludec, Low dose, insulin degludec, Medium dose, insulin degludec |
| placeboAdministered subcutaneously (s.c., under the skin) | Drug | High dose, insulin degludec, IDegAsp 50, Low dose, insulin degludec, Medium dose, insulin degludec |
| insulin degludec/insulin aspart 50Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin) | Drug | IDegAsp 50 |
Primary outcome
Frequency of adverse events (AEs)
Time frame: From dosing visit and until follow-up 7-21 days after last dosing visit
2 secondary outcomes
Area under the serum insulin concentration curve
Time frame: 0-96 hours after dosing
Area under the glucose infusion rate curve
Time frame: 0-24 hours after dosing
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 15 Jan 2016.
- 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 degludec and insulin degludec/insulin aspart 50 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 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 15 Jan 2016. 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?
Frequency of adverse events (AEs) (time frame: From dosing visit and until follow-up 7-21 days after last dosing visit). 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 15 Jan 2016.