DiabetesPhase 1NCT00976326
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
A Phase 1 study testing insulin degludec in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Slovakia.
Trial summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- insulin degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSlovakia
- Study dates
- Aug 2009to Mar 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator
- Body mass index maximum 40.0 kg/m^2
Who cannot join
- Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.
- Being tested
- insulin degludec
- 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
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
| Study group | Role | What they receive |
|---|---|---|
| A: Healthy volunteers | Experimental | Not described Receives: Drug: insulin degludec |
| B: Subjects with mild liver impairment | Experimental | Not described Receives: Drug: insulin degludec |
| C: Subjects with moderate liver impairment | Experimental | Not described Receives: Drug: insulin degludec |
| D: Subjects with severe liver impairment | Experimental | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the NN1250 concentration-time curve after single-dose
Measured: from 0 to 120 hours
Secondary outcomes (3)
Maximum observed NN1250 concentration after single-dose
Measured: from 0 to 120 hours
Renal clearance of NN1250
Measured: from 0 to 24 hours
Number of adverse events
Measured: from Visit 2, Day -1 until Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT00976326
- Sponsor's protocol ID
- NN1250-1989
- Other IDs
- 2009-009465-34, 2009
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kupcova V, Arold G, Roepstorff C, Hojbjerre M, Klim S, Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig. 2014 Feb;34(2):127-33. doi: 10.1007/s40261-013-0154-1.
PubMed 24277680
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00976326
- Acronym / sponsor ID
- NN1250-1989
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Sep 2009 (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 was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Healthy volunteers | Experimental | Drug: insulin degludec |
| B: Subjects with mild liver impairment | Experimental | Drug: insulin degludec |
| C: Subjects with moderate liver impairment | Experimental | Drug: insulin degludec |
| D: Subjects with severe liver impairment | Experimental | Drug: insulin degludec |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator
- Body mass index maximum 40.0 kg/m^2
Key exclusion criteria (3 listed)
- Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking 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 |
|---|---|---|
| insulin degludecThe dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin) | Drug | A: Healthy volunteers, B: Subjects with mild liver impairment, C: Subjects with moderate liver impairment, D: Subjects with severe liver impairment |
Primary outcome
Area under the NN1250 concentration-time curve after single-dose
Time frame: from 0 to 120 hours
3 secondary outcomes
Maximum observed NN1250 concentration after single-dose
Time frame: from 0 to 120 hours
Renal clearance of NN1250
Time frame: from 0 to 24 hours
Number of adverse events
Time frame: from Visit 2, Day -1 until Follow-up Visit
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 20 Jan 2017.
- Results publication: PubMed 24277680Kupcova V, Arold G, Roepstorff C, Hojbjerre M, Klim S, Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig. 2014 Feb;34(2):127-33. doi: 10.1007/s40261-013-0154-1.
- 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 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Slovakia.
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 2 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 20 Jan 2017. 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 Slovakia. 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 NN1250 concentration-time curve after single-dose (time frame: from 0 to 120 hours). 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 NCT00976326, 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 20 Jan 2017.