DiabetesPhase 1NCT02146079
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian 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 Japan.
Trial summary
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- 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
- 44 participants
- Where
- 1 siteJapan
- Study dates
- 21 May 2014to 20 Oct 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Japanese and Caucasian subjects
- Age between 20 and 55 years (both inclusive) at the time of signing informed consent
- Body weight of equal to or above 54.0 kg
- Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
- For Japanese subjects only: both parents Japanese
- For Caucasian subjects only: both parents Caucasian
Who cannot join
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Calcitonin above or equal to 50 ng/L
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits
- Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
- Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian 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
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
placeboDrug
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 0.5 mg | Experimental | Dose-escalation trial Receives: Drug: semaglutide |
| Semaglutide placebo 0.5 mg | Placebo comparator | Not described Receives: Drug: placebo |
| Semaglutide 1.0 mg | Experimental | Dose-escalation trial Receives: Drug: semaglutide |
| Semaglutide placebo 1.0 mg | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma semaglutide concentration-time curve
Measured: During a dosing interval (0-168 hours) at steady state
Secondary outcomes (3)
Maximum observed plasma semaglutide concentration at steady state
Measured: 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
Change in body weight from baseline to the end of treatment
Measured: Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
Number of treatment emergent adverse events (TEAEs) from baseline to follow-up
Measured: From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start21 May 2014
- Primary completion20 Oct 2014
- Study completion20 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 44 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
- NCT02146079
- Sponsor's protocol ID
- NN9535-3634
- Other IDs
- U1111-1147-6660, JapicCTI-142550
- Status last verified
- Apr 2018
- First submitted
- 21 May 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Apr;35(4):531-544. doi: 10.1007/s12325-018-0677-1. Epub 2018 Mar 13.
PubMed 29536338
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT02146079
- Acronym / sponsor ID
- NN9535-3634
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 May 2014 (actual)
- Primary completion
- 20 Oct 2014 (actual)
- Study completion
- 20 Oct 2014 (actual)
- First posted
- 23 May 2014 (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 Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 0.5 mg | Experimental | Drug: semaglutideDose-escalation trial |
| Semaglutide placebo 0.5 mg | Placebo comparator | Drug: placebo |
| Semaglutide 1.0 mg | Experimental | Drug: semaglutideDose-escalation trial |
| Semaglutide placebo 1.0 mg | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male Japanese and Caucasian subjects
- Age between 20 and 55 years (both inclusive) at the time of signing informed consent
- Body weight of equal to or above 54.0 kg
- Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
Key exclusion criteria (7 listed)
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Calcitonin above or equal to 50 ng/L
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits
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 |
|---|---|---|
| semaglutideSubjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule | Drug | Semaglutide 0.5 mg, Semaglutide 1.0 mg |
| placeboSubjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule. | Drug | Semaglutide placebo 0.5 mg, Semaglutide placebo 1.0 mg |
Primary outcome
Area under the plasma semaglutide concentration-time curve
Time frame: During a dosing interval (0-168 hours) at steady state
3 secondary outcomes
Maximum observed plasma semaglutide concentration at steady state
Time frame: 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
Change in body weight from baseline to the end of treatment
Time frame: Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
Number of treatment emergent adverse events (TEAEs) from baseline to follow-up
Time frame: From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)
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 18 Apr 2018.
- Results publication: PubMed 29536338Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Apr;35(4):531-544. doi: 10.1007/s12325-018-0677-1. Epub 2018 Mar 13.
- 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 Japan.
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 7 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 18 Apr 2018. 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 Japan. 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?
Area under the plasma semaglutide concentration-time curve (time frame: During a dosing interval (0-168 hours) at steady state). 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 NCT02146079, which also lists 1 linked publication.
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 18 Apr 2018.