DiabetesPhase 1NCT01507272
Safety and Tolerability of Liraglutide in Healthy Male Volunteers
A Phase 1 study testing liraglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects of any ethnic origin
- Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
- Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
- Body mass index within the range 20-27 kg/m^2, inclusive
Who cannot join
- Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
- History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
- Alcohol intake within 48 hours of visit
- Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
- History of significant drug allergy or drug hypersensitivity
- Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
- Subjects who drink more than 8 cups of tea/coffee per day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Novo Nordisk Investigational Site
Manchester, M15 6SH
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).
- Being tested
- 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.
liraglutideDrug
Also called NNC 90-1170
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
liraglutideDrug
Also called NNC 90-1170
Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
placeboDrug
Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
placeboDrug
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
| Study group | Role | What they receive |
|---|---|---|
| NNC 90-1170 (liraglutide) | Experimental | Not described Receives: Drug: liraglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve)
Secondary outcomes (3)
Cmax, maximum concentration
tmax, time to maximum concentration
t½, terminal half-life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMar 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.
- Publications (2)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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
- NCT01507272
- Sponsor's protocol ID
- NN2211-1149
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Elbrond B, Jakobsen G, Larsen S, Agerso H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002 Aug;25(8):1398-404. doi: 10.2337/diacare.25.8.1398.
PubMed 12145241Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. doi: 10.1016/s0928-0987(03)00073-3.
PubMed 12791417
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01507272
- Acronym / sponsor ID
- NN2211-1149
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 10 Jan 2012 (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 assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC 90-1170 (liraglutide) | Experimental | Drug: liraglutide |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects of any ethnic origin
- Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
- Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
- Body mass index within the range 20-27 kg/m^2, inclusive
Key exclusion criteria (7 listed)
- Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
- History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
- Alcohol intake within 48 hours of visit
- Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
- History of significant drug allergy or drug hypersensitivity
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 |
|---|---|---|
| liraglutideAlso: NNC 90-1170Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order | Drug | NNC 90-1170 (liraglutide) |
| liraglutideAlso: NNC 90-1170Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg | Drug | NNC 90-1170 (liraglutide) |
| placeboAdministered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered | Drug | Placebo |
| placeboAdministered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order | Drug | Placebo |
Primary outcome
AUC (area under the curve)
3 secondary outcomes
Cmax, maximum concentration
tmax, time to maximum concentration
t½, terminal half-life
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 24 Jan 2017.
- Results publication: PubMed 12145241Elbrond B, Jakobsen G, Larsen S, Agerso H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002 Aug;25(8):1398-404. doi: 10.2337/diacare.25.8.1398.
- Results publication: PubMed 12791417Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. doi: 10.1016/s0928-0987(03)00073-3.
- 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 liraglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 7 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 24 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
AUC (area under the curve). 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 NCT01507272, which also lists 2 linked publications.
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 24 Jan 2017.