DiabetesPhase 1NCT00983021
Safety and Tolerability of NN9068 in Healthy Male Volunteers
A Phase 1 study testing insulin degludec/liraglutide, insulin degludec and liraglutide 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 clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068. The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- What is being tested?
- insulin degludec/liraglutide, insulin degludec and liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Dec 2009
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
- Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
- Body weight between 60 kg and 90 kg (both inclusive)
Who cannot join
- Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.
The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.
- Being tested
- insulin degludec/liraglutide, insulin degludec, liraglutide, placebo
- 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 degludec/liraglutideDrug
Also called NN9068
Single, simultaneous dose of NN9068, injected s.c. (under the skin)
insulin degludecDrug
Also called NN1250
Single, simultaneous dose of NN1250, injected s.c. (under the skin)
liraglutideDrug
Also called NN2211
Single, simultaneous dose of NN2211, injected s.c. (under the skin)
placeboDrug
Single, simultaneous dose of placebo, injected s.c. (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: insulin degludec/liraglutide; Drug: placebo |
| B | Experimental | Not described Receives: Drug: insulin degludec; Drug: placebo |
| C | Active comparator | Not described Receives: Drug: liraglutide; Drug: placebo |
| D | Experimental | Not described Receives: Drug: insulin degludec; Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
Measured: assessed 0-96 hours after trial product administration
Secondary outcomes (2)
The area under the NN2211 concentration-time curve after single-dose
Measured: assessed 0-72 hours after trial product administration
The area under the NN1250 concentration-time curve after single-dose
Measured: assessed 0-96 hours after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- 24 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
- NCT00983021
- Sponsor's protocol ID
- NN9068-3632
- Other IDs
- 2009-011269-95, U1111-1111-8859, 2009
- Status last verified
- Feb 2017
- First submitted
- 22 Sep 2009
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.
PubMed 25998481
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00983021
- Acronym / sponsor ID
- NN9068-3632
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 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 is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.
The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: insulin degludec/liraglutide, Drug: placebo |
| B | Experimental | Drug: insulin degludec, Drug: placebo |
| C | Active comparator | Drug: liraglutide, Drug: placebo |
| D | Experimental | Drug: insulin degludec, Drug: liraglutide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
- Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
- Body weight between 60 kg and 90 kg (both inclusive)
Key exclusion criteria (1 listed)
- Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, 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 degludec/liraglutideAlso: NN9068Single, simultaneous dose of NN9068, injected s.c. (under the skin) | Drug | A |
| insulin degludecAlso: NN1250Single, simultaneous dose of NN1250, injected s.c. (under the skin) | Drug | B, D |
| liraglutideAlso: NN2211Single, simultaneous dose of NN2211, injected s.c. (under the skin) | Drug | C, D |
| placeboSingle, simultaneous dose of placebo, injected s.c. (under the skin) | Drug | A, B, C |
Primary outcome
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
Time frame: assessed 0-96 hours after trial product administration
2 secondary outcomes
The area under the NN2211 concentration-time curve after single-dose
Time frame: assessed 0-72 hours after trial product administration
The area under the NN1250 concentration-time curve after single-dose
Time frame: assessed 0-96 hours after trial product administration
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 Feb 2017.
- Results publication: PubMed 25998481Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.
- 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/liraglutide, insulin degludec and liraglutide 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 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 8 Feb 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 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?
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes (time frame: assessed 0-96 hours after trial product administration). 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 NCT00983021, 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 Feb 2017.