DiabetesPhase 1NCT02557620
Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
A Phase 1 study testing semaglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- 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
- 113 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Apr 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
- Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
- HbA1c (glycosylated haemoglobin) below 6.5%
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- History of pancreatitis (acute or chronic)
- Screening calcitonin equal or above 50 ng/L
- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy 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
Administered subcutaneously (s.c., under the skin)once daily or once weekly.
placeboDrug
Administered subcutaneously (s.c., under the skin)once daily or once weekly.
| Study group | Role | What they receive |
|---|---|---|
| semaglutide OD + placebo semaglutide OW | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| placebo semaglutide OW + placebo semaglutide OD | Placebo comparator | Not described Receives: Drug: placebo |
| semaglutide OW + placebo semaglutide OD | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide concentration-time curves
Measured: At steady-state from 0 to168 hours after dosing on day 78
Secondary outcomes (4)
Maximum observed semaglutide plasma concentration
Measured: At steady-state derived from the concentration-time curves, within 168 hours from day 78
Number of treatment emergent adverse events (TEAEs)
Measured: From baseline (day 1, post-dose) to last follow-up visit (day 120)
Area under the the single dose concentration-time curve
Measured: From 0 to 300 min after administration of paracetamol (1.5 g) at day 51
Area under the the single dose concentration-time curve
Measured: From 0 to 300 min after administration of paracetamol (1.5 g) at day 79
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- 113 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
- NCT02557620
- Sponsor's protocol ID
- NN9535-4215
- Other IDs
- 2014-005171-84, U1111-1164-2741, 2014
- Status last verified
- Jan 2017
- First submitted
- 22 Sep 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
- ClinicalTrials.gov ID
- NCT02557620
- Acronym / sponsor ID
- NN9535-4215
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Sep 2015 (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 compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| semaglutide OD + placebo semaglutide OW | Experimental | Drug: semaglutide, Drug: placebo |
| placebo semaglutide OW + placebo semaglutide OD | Placebo comparator | Drug: placebo |
| semaglutide OW + placebo semaglutide OD | Experimental | Drug: semaglutide, Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
- Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
- HbA1c (glycosylated haemoglobin) below 6.5%
Key exclusion criteria (5 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- History of pancreatitis (acute or chronic)
- Screening calcitonin equal or above 50 ng/L
- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
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 |
|---|---|---|
| semaglutideAdministered subcutaneously (s.c., under the skin)once daily or once weekly. | Drug | semaglutide OD + placebo semaglutide OW, semaglutide OW + placebo semaglutide OD |
| placeboAdministered subcutaneously (s.c., under the skin)once daily or once weekly. | Drug | placebo semaglutide OW + placebo semaglutide OD, semaglutide OD + placebo semaglutide OW, semaglutide OW + placebo semaglutide OD |
Primary outcome
Area under the semaglutide concentration-time curves
Time frame: At steady-state from 0 to168 hours after dosing on day 78
4 secondary outcomes
Maximum observed semaglutide plasma concentration
Time frame: At steady-state derived from the concentration-time curves, within 168 hours from day 78
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (day 1, post-dose) to last follow-up visit (day 120)
Area under the the single dose concentration-time curve
Time frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 51
Area under the the single dose concentration-time curve
Time frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 79
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 4 Jan 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 semaglutide in people with Diabetes and Healthy, 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 4 inclusion and 5 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 4 Jan 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 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. 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 semaglutide concentration-time curves (time frame: At steady-state from 0 to168 hours after dosing on day 78). 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 4 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.