DiabetesPhase 1NCT02162407
A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin
A Phase 1 study testing insulin detemir and human soluble insulin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men only
- What is being tested?
- insulin detemir and human soluble insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- Oct 1999to Dec 1999
- 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 19 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy males between 19 and 50 years inclusive
- The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
- Body Mass Index (BMI) below 27 kg/m^2
- Fasting blood glucose maximum 6 mmol/l
Who cannot join
- Participation in any other clinical trial involving other investigational products within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique
This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.
- Being tested
- insulin detemir, human soluble insulin
- 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 detemirDrug
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
human soluble insulinDrug
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir 60 pmol/kg/min | Experimental | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) Receives: Drug: insulin detemir |
| Insulin detemir 120 pmol/kg/min | Experimental | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) Receives: Drug: insulin detemir |
| Human insulin 6 pmol/kg/min | Active comparator | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) Receives: Drug: human soluble insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration
Measured: 8 hours
Secondary outcomes (4)
Steady state glucose infusion rate (GIR)
Measured: 8 hours
Steady state insulin interstitial concentration
Measured: 8 hours
Ratio of steady state serum insulin concentration to interstitial insulin concentration
Measured: 8 hours
Insulin concentration profiles
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startOct 1999
- Primary completionDec 1999
- Study completionDec 1999
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
- None (open label)
- Enrolment
- 13 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
- NCT02162407
- Sponsor's protocol ID
- NN304-1196
- Status last verified
- Jun 2014
- First submitted
- 22 May 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique
- ClinicalTrials.gov ID
- NCT02162407
- Acronym / sponsor ID
- NN304-1196
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 12 Jun 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 study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir 60 pmol/kg/min | Experimental | Drug: insulin detemirSubjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Insulin detemir 120 pmol/kg/min | Experimental | Drug: insulin detemirSubjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Human insulin 6 pmol/kg/min | Active comparator | Drug: human soluble insulinSubjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males between 19 and 50 years inclusive
- The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
- Body Mass Index (BMI) below 27 kg/m^2
- Fasting blood glucose maximum 6 mmol/l
Key exclusion criteria (1 listed)
- Participation in any other clinical trial involving other investigational products within the last 3 months
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 detemirGiven as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp | Drug | Insulin detemir 120 pmol/kg/min, Insulin detemir 60 pmol/kg/min |
| human soluble insulinGiven as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp | Drug | Human insulin 6 pmol/kg/min |
Primary outcome
Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration
Time frame: 8 hours
4 secondary outcomes
Steady state glucose infusion rate (GIR)
Time frame: 8 hours
Steady state insulin interstitial concentration
Time frame: 8 hours
Ratio of steady state serum insulin concentration to interstitial insulin concentration
Time frame: 8 hours
Insulin concentration profiles
Time frame: 8 hours
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 12 Jun 2014.
- 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 detemir and human soluble insulin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Austria.
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 4 inclusion and 1 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 12 Jun 2014. 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 Austria. 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?
Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration (time frame: 8 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 12 Jun 2014.