DiabetesPhase 1NCT01514487
Comparison of Three Liraglutide Formulations in Healthy Volunteers
A Phase 1 study testing liraglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Australia.
Trial summary
This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Jan 2005to 30 Mar 2005
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects
- Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
- Body Mass Index (BMI) of 18-27 kg/m^2, both inclusive
Who cannot join
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
- metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
- that may interfere with the objectives of the study, as judged by the investigator
- Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
- Impaired renal function
- Uncontrolled treated/untreated hypertension
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- Any clinically significant abnormal ECG
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunideficiency virus) antibodies
- Known or suspected allergy to trial product(s) or related products
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
- Prescription or non-prescription medication, except for paracetamol and vitamins
- History of alcoholism or drug abuse during the last 12 months
- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7
This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.
- Being tested
- liraglutide
- 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
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
| Study group | Role | What they receive |
|---|---|---|
| pH 7.7 | Experimental | Not described Receives: Drug: liraglutide |
| pH 7.9 | Experimental | Not described Receives: Drug: liraglutide |
| pH 8.15 | Experimental | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Curve (0-t)
Cmax, maximum concentration
Secondary outcomes (5)
Area under the curve (0-infinity)
tmax, time to reach Cmax
t½, terminal half-life
Terminal elimination 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 posted23 Jan 2012 (estimated)
- Study start13 Jan 2005
- Primary completion30 Mar 2005
- Study completion30 Mar 2005
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
- 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
- NCT01514487
- Sponsor's protocol ID
- NN2211-1636
- Status last verified
- Feb 2017
- First submitted
- 17 Jan 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7
- ClinicalTrials.gov ID
- NCT01514487
- Acronym / sponsor ID
- NN2211-1636
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2005 (actual)
- Primary completion
- 30 Mar 2005 (actual)
- Study completion
- 30 Mar 2005 (actual)
- First posted
- 23 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 Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pH 7.7 | Experimental | Drug: liraglutide |
| pH 7.9 | Experimental | Drug: liraglutide |
| pH 8.15 | Experimental | Drug: liraglutide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
- Body Mass Index (BMI) of 18-27 kg/m^2, both inclusive
Key exclusion criteria (15 listed)
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
- metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
- that may interfere with the objectives of the study, as judged by the investigator
- Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
- Impaired renal function
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 |
|---|---|---|
| liraglutideOne single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously | Drug | pH 7.7, pH 7.9, pH 8.15 |
Primary outcome
Area under the Curve (0-t)
Cmax, maximum concentration
5 secondary outcomes
Area under the curve (0-infinity)
tmax, time to reach Cmax
t½, terminal half-life
Terminal elimination 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 1 Mar 2017.
- 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 Australia.
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 15 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 1 Mar 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 Australia. 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 Curve (0-t). The study lists 2 primary outcomes in all. 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 1 Mar 2017.