DiabetesPhase 1NCT01272973
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jul 2011
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male subjects, based on an assessment of medical history, physical examination and
- BMI between 21 and 30 kg/m2 (21 inclusive)
Who cannot join
- Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
- Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
- The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- semaglutide, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
placeboDrug
Placebo (oral) administered once daily for 10 weeks.
semaglutideDrug
Also called NN9924
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
| Study group | Role | What they receive |
|---|---|---|
| Oral 1 | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| Oral 2 | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| Oral 3 | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| S.c. | Active comparator | Not described Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs)
Measured: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Secondary outcomes (5)
Hypoglycaemic episodes
Measured: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Laboratory safety variables (haematology, biochemistry, and urinalysis)
Measured: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Maximum plasma concentration of NN9924
Measured: after dosing on the 68th, 69th and 70th Day
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Measured: after dosing on the 68th, 69th and 70th day
Terminal phase elimination half-life
Measured: from last dose (day 70) to follow-up visit 91-105 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 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
- NCT01272973
- Sponsor's protocol ID
- NN9924-3692
- Other IDs
- U1111-1118-0257, 2010-019951-23
- Status last verified
- Feb 2015
- First submitted
- 7 Jan 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01272973
- Acronym / sponsor ID
- NN9924-3692
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Jan 2011 (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 safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral 1 | Experimental | Drug: semaglutide, Drug: placebo |
| Oral 2 | Experimental | Drug: semaglutide, Drug: placebo |
| Oral 3 | Experimental | Drug: semaglutide, Drug: placebo |
| S.c. | Active comparator | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects, based on an assessment of medical history, physical examination and
- BMI between 21 and 30 kg/m2 (21 inclusive)
Key exclusion criteria (3 listed)
- Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
- Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
- The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
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 |
|---|---|---|
| semaglutideSemaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level. | Drug | Oral 1, Oral 2, Oral 3 |
| placeboPlacebo (oral) administered once daily for 10 weeks. | Drug | Oral 1, Oral 2, Oral 3 |
| semaglutideAlso: NN9924Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level. | Drug | S.c. |
Primary outcome
Frequency of adverse events (AEs)
Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
5 secondary outcomes
Hypoglycaemic episodes
Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Laboratory safety variables (haematology, biochemistry, and urinalysis)
Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Maximum plasma concentration of NN9924
Time frame: after dosing on the 68th, 69th and 70th Day
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Time frame: after dosing on the 68th, 69th and 70th day
Terminal phase elimination half-life
Time frame: from last dose (day 70) to follow-up visit 91-105 days after first 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 Feb 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 semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, 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 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 Feb 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 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?
Frequency of adverse events (AEs) (time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose). 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 23 Feb 2015.