DiabetesPhase 1NCT01076634
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
A Phase 1 study testing insulin degludec in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- 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
- 33 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2010to Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
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 more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin degludec
- 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.
insulin degludecDrug
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
insulin degludecDrug
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| IDeg 100 U/mL | Experimental | Not described Receives: Drug: insulin degludec |
| IDeg 200 U/mL | 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 glucose infusion rate curve during one dosing interval at steady-date"
Measured: After 8 days of treatment
Secondary outcomes (2)
Area under the serum Insulin Degludec concentration-time curve
Measured: During one dosing interval at steady state
Area under the serum Insulin Degludec concentration-time curve
Measured: From 0 to 24 hours after single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT01076634
- Sponsor's protocol ID
- NN1250-3678
- Other IDs
- 2009-014555-68, U1111-1112-7714, 2009
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2010
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.
PubMed 23749405
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01076634
- Acronym / sponsor ID
- NN1250-3678
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Feb 2010 (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 pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDeg 100 U/mL | Experimental | Drug: insulin degludec |
| IDeg 200 U/mL | Experimental | Drug: insulin degludec |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
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 more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches 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 degludec0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days. | Drug | IDeg 100 U/mL |
| insulin degludec0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days. | Drug | IDeg 200 U/mL |
Primary outcome
Area under the glucose infusion rate curve during one dosing interval at steady-date"
Time frame: After 8 days of treatment
2 secondary outcomes
Area under the serum Insulin Degludec concentration-time curve
Time frame: During one dosing interval at steady state
Area under the serum Insulin Degludec concentration-time curve
Time frame: From 0 to 24 hours after 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 23 Jan 2017.
- Results publication: PubMed 23749405Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.
- 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 Diabetes Mellitus, Type 1, 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 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 23 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 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?
Area under the glucose infusion rate curve during one dosing interval at steady-date" (time frame: After 8 days of treatment). 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 NCT01076634, 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 23 Jan 2017.