DiabetesPhase 1NCT00851773
Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects
A Phase 1 study testing semaglutide 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 clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- What is being tested?
- semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Oct 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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- For Caucasian or Japanese volunteers the following applies:
- Informed consent obtained before any trial-related activities
- Body weight between 54 and 90 kg (both inclusive)
- Body mass index (BMI) between 18.5 and 24.9 kg/m2 (both inclusive)
- HbA1c below 6.0 %
- Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
- Subjects who are sexually active and have partners who are or could be pregnant are willing and required to use a barrier method of contraception (e.g. condom) for the duration of the study and for 90 days following the last dose of study medication
- Japanese passport holder, Japanese-born parents, lived outside Japan for 5 years or less
Who cannot join
- Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not to be clinically significant by the investigator
- Any abnormal ECG findings at the screening, considered to be clinically significant by the Investigator
- Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, considered to be clinically significant by the Investigator
- Previous randomised in this trial (not applicable for stand-by volunteers)
- Blood pressure in supine position at the screening, after resting for 5 min, and in the standing position after standing for 1 min, consistently outside the ranges 90 - 140 mmHg systolic or 40 - 90 mmHg diastolic
- Heart rate in supine position at the screening, after resting for 5 min, consistently above 100 beats/min
Show all 21Show fewer
- Alcohol intake within 48 hours prior to the screening and admission (examined by alcohol breath test)
- Hepatitis B surface antigen, Hepatitis C antibodies or Human Immunodeficiency Virus (HIV) antibodies positive
- History of significant allergy or hypersensitivity
- Known or suspected allergy to trial product or related products
- History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 21 units (U) weekly: One unit of alcohol equals 1/2 pint (approximately 250 mL) of beer or lager, or one glass of wine or Japanese sake, or 1/6 gill (approximately 20 mL) of spirits)
- Subjects who smoke more than 10 cigarettes, or the equivalent, per day or is unwilling to refrain from smoking whenever required for the trial procedure
- Use of prescription drugs within 3 weeks prior to dosing, non-prescription drugs within 1 week prior to dosing except for vitamins, minerals and nutritional supplements
- Received any investigational drug within 12 weeks prior to the planned first dosing
- Subjects who have taken part in strenuous exercise within 48 hours prior to first dosing, due to interference with the hepatic microsomal monooxygenase system. The Investigator or Sub-Investigator will evaluate whether strenuous exercise has been undertaken
- Loss of more than 400 mL blood in total within the last 12 weeks or more than 200 mL blood in total within the last 4 weeks prior to first dosing
- Subjects with a first-degree relative with diabetes mellitus
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Possibility that the subject will not comply with the protocol
- Subjects who in the opinion of the Investigator or Sub-Investigator should not participate in the trial
- Subjects with known history of either Type 1 or Type 2 diabetes mellitus are excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Profiles of NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections.
This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
- Being tested
- semaglutide, 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.
semaglutideDrug
0.1 mg once weekly, s.c. injection
semaglutideDrug
0.2 mg once weekly, s.c. injection
semaglutideDrug
0.4 mg once weekly, s.c. injection
semaglutideDrug
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
semaglutideDrug
Also called NN9535
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
placeboDrug
0.1 mg once weekly, s.c. injection
placeboDrug
0.2 mg once weekly, s.c. injection
placeboDrug
0.4 mg once weekly, s.c. injection
placeboDrug
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
placeboDrug
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: semaglutide |
| B | Experimental | Not described Receives: Drug: semaglutide |
| C | Experimental | Not described Receives: Drug: semaglutide |
| D | Experimental | Not described Receives: Drug: semaglutide |
| E | Experimental | Not described Receives: Drug: semaglutide |
| F1 | Placebo comparator | Not described Receives: Drug: placebo |
| F2 | Placebo comparator | Not described Receives: Drug: placebo |
| F3 | Placebo comparator | Not described Receives: Drug: placebo |
| F4 | Placebo comparator | Not described Receives: Drug: placebo |
| F5 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: at all scheduled visits (2 - 14) following screening
Secondary outcomes (8)
Frequency of hypoglycaemic episodes
Measured: at all scheduled visits (2 - 14) following screening
Vital signs (blood pressure and pulse)
Measured: at all scheduled visits (2 - 14) including screening (visit 1)
12-lead ECG (electrocardiogram)
Measured: at all scheduled visits (2 - 14) including screening (visit 1)
Haematology
Measured: at all scheduled visits (2 - 14) including screening (visit 1)
Biochemistry
Measured: at all scheduled visits (2 - 14) including screening (visit 1)
Urinalysis
Measured: at all scheduled visits (2 - 14) including screening (visit 1)
Calcitonin
Measured: at screening (visit 1) and at visits 2, 9 and 14
Antibody development against N9535
Measured: at visits 2 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionOct 2009
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
- 84 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
- NCT00851773
- Sponsor's protocol ID
- NN9535-3633
- Other IDs
- 2008-006325-13, 2008
- Status last verified
- Feb 2015
- First submitted
- 25 Feb 2009
- 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
- A Randomised, Double Blind, Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Profiles of NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections.
- ClinicalTrials.gov ID
- NCT00851773
- Acronym / sponsor ID
- NN9535-3633
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Feb 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 assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: semaglutide |
| B | Experimental | Drug: semaglutide |
| C | Experimental | Drug: semaglutide |
| D | Experimental | Drug: semaglutide |
| E | Experimental | Drug: semaglutide |
| F1 | Placebo comparator | Drug: placebo |
| F2 | Placebo comparator | Drug: placebo |
| F3 | Placebo comparator | Drug: placebo |
| F4 | Placebo comparator | Drug: placebo |
| F5 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For Caucasian or Japanese volunteers the following applies:
- Informed consent obtained before any trial-related activities
- Body weight between 54 and 90 kg (both inclusive)
- Body mass index (BMI) between 18.5 and 24.9 kg/m2 (both inclusive)
- HbA1c below 6.0 %
Key exclusion criteria (21 listed)
- Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not to be clinically significant by the investigator
- Any abnormal ECG findings at the screening, considered to be clinically significant by the Investigator
- Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, considered to be clinically significant by the Investigator
- Previous randomised in this trial (not applicable for stand-by volunteers)
- Blood pressure in supine position at the screening, after resting for 5 min, and in the standing position after standing for 1 min, consistently outside the ranges 90 - 140 mmHg systolic or 40 - 90 mmHg diastolic
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 |
|---|---|---|
| semaglutide0.1 mg once weekly, s.c. injection | Drug | A |
| semaglutide0.2 mg once weekly, s.c. injection | Drug | B |
| semaglutide0.4 mg once weekly, s.c. injection | Drug | C |
| semaglutide0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection | Drug | D |
| semaglutideAlso: NN95350.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection | Drug | E |
| placebo0.1 mg once weekly, s.c. injection | Drug | F1 |
| placebo0.2 mg once weekly, s.c. injection | Drug | F2 |
| placebo0.4 mg once weekly, s.c. injection | Drug | F3 |
| placebo0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection | Drug | F4 |
| placebo0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection | Drug | F5 |
Primary outcome
Adverse events
Time frame: at all scheduled visits (2 - 14) following screening
8 secondary outcomes
Frequency of hypoglycaemic episodes
Time frame: at all scheduled visits (2 - 14) following screening
Vital signs (blood pressure and pulse)
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
12-lead ECG (electrocardiogram)
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Haematology
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Biochemistry
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Urinalysis
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Calcitonin
Time frame: at screening (visit 1) and at visits 2, 9 and 14
Antibody development against N9535
Time frame: at visits 2 and 14
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 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 21 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 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?
Adverse events (time frame: at all scheduled visits (2 - 14) following screening). 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.