DiabetesPhase 1NCT01511159
Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
A Phase 1 study testing liraglutide and insulin human 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 determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- What is being tested?
- liraglutide and insulin human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2001to Dec 2001
- 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
- No clinically important abnormal physical findings
- No clinically relevant abnormalities in the results of laboratory screening evaluation
- Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
- Normal (or abnormal but not clinically significant) blood pressure and heart rate
- Body Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant
- Non-smoker
- Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
- FVC ratio at least 75% of predicted normal for age, gender and height
Who cannot join
- A clinically significant illness or infection requiring treatment within the last two months
- Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
- Subjects with first and/or second degree relative(s) with diabetes mellitus
- Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
- Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
- Current addiction to alcohol or substances of abuse
- Females
- Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection
This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.
- Being tested
- liraglutide, placebo, insulin human
- 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
Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
placeboDrug
Single dose by inhalation. Progression to open-label trial part will be based on safety data
liraglutideDrug
Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order
liraglutideDrug
Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order
insulin humanDrug
Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order
insulin humanDrug
Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order
liraglutideDrug
Also called NNC 90-1170
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
| Study group | Role | What they receive |
|---|---|---|
| NNC 90-1170, initial dose | Experimental | Not described Receives: Drug: liraglutide; Drug: placebo |
| NNC 90-1170 | Experimental | Not described Receives: Drug: liraglutide |
| Insulin | Active comparator | Not described Receives: Drug: insulin human |
| NNC 90-1170, final dose | Experimental | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the areas under the plasma NN 90-1170 curves
Secondary outcomes (6)
The maximum concentration (Cmax)
The time to maximum concentration (tmax)
Mean residence time (MRT)
Area under the curve
Terminal rate constant
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startOct 2001
- Primary completionDec 2001
- Study completionDec 2001
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
- 32 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
- NCT01511159
- Sponsor's protocol ID
- NN2211-1464
- Status last verified
- Mar 2015
- First submitted
- 12 Jan 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection
- ClinicalTrials.gov ID
- NCT01511159
- Acronym / sponsor ID
- NN2211-1464
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 18 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 determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NNC 90-1170, initial dose | Experimental | Drug: liraglutide, Drug: placebo |
| NNC 90-1170 | Experimental | Drug: liraglutide |
| Insulin | Active comparator | Drug: insulin human |
| NNC 90-1170, final dose | Experimental | Drug: liraglutide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- No clinically important abnormal physical findings
- No clinically relevant abnormalities in the results of laboratory screening evaluation
- Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
- Normal (or abnormal but not clinically significant) blood pressure and heart rate
- Body Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant
Key exclusion criteria (8 listed)
- A clinically significant illness or infection requiring treatment within the last two months
- Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
- Subjects with first and/or second degree relative(s) with diabetes mellitus
- Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
- Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
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 |
|---|---|---|
| liraglutideSingle dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data | Drug | NNC 90-1170, initial dose |
| placeboSingle dose by inhalation. Progression to open-label trial part will be based on safety data | Drug | NNC 90-1170, initial dose |
| liraglutideSingle dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order | Drug | NNC 90-1170 |
| liraglutideSingle dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order | Drug | NNC 90-1170 |
| insulin humanSingle dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order | Drug | Insulin |
| insulin humanSingle dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order | Drug | Insulin |
| liraglutideAlso: NNC 90-117024 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation | Drug | NNC 90-1170, final dose |
Primary outcome
Ratio of the areas under the plasma NN 90-1170 curves
6 secondary outcomes
The maximum concentration (Cmax)
The time to maximum concentration (tmax)
Mean residence time (MRT)
Area under the curve
Terminal rate constant
Adverse events
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 26 Mar 2015.
- 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 and insulin human 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 8 inclusion and 8 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 26 Mar 2015. 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. 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?
Ratio of the areas under the plasma NN 90-1170 curves. 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 26 Mar 2015.