Healthy Volunteers (Diabetes Mellitus, Type 2)Phase 1NCT05232708
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
A Phase 1 study testing Semaglutide B, 1.34 mg/mL and Semaglutide D, 1.0 mg/mL in people with Healthy Volunteers (Diabetes Mellitus, Type 2), run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (Diabetes Mellitus, Type 2)
- What is being tested?
- Semaglutide B, 1.34 mg/mL and Semaglutide D, 1.0 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2022to 30 Aug 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Aged 20-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)
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
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
- Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits).
- Positive alcohol test at screening.
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- Abuse or intake of drugs, defined as any of the below:
- Known or suspected drug or chemical substance abuse within 1 year before screening
- Positive drug of abuse test at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.
- Being tested
- Semaglutide B, 1.34 mg/mL, Semaglutide D, 1.0 mg/mL
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide B, 1.34 mg/mLDrug
Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Semaglutide D, 1.0 mg/mLDrug
Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
Semaglutide D, 1.0 mg/mLDrug
Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
Semaglutide B, 1.34 mg/mLDrug
Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL | Experimental | Not described Receives: Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide D, 1.0 mg/mL |
| Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL | Experimental | Not described Receives: Drug: Semaglutide D, 1.0 mg/mL; Drug: Semaglutide B, 1.34 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg
Measured in h*nmol/L
Measured: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration
Measured in nmol/L
Measured: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start19 Jan 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (Diabetes Mellitus, Type 2)Studies 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232708
- Sponsor's protocol ID
- NN9535-4885
- Other IDs
- 2021-003216-25, U1111-1266-4076
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
- ClinicalTrials.gov ID
- NCT05232708
- Acronym / sponsor ID
- NN9535-4885
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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.
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL | Experimental | Drug: Semaglutide B, 1.34 mg/mL, Drug: Semaglutide D, 1.0 mg/mL |
| Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL | Experimental | Drug: Semaglutide D, 1.0 mg/mL, Drug: Semaglutide B, 1.34 mg/mL |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female
- Aged 20-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)
Key exclusion criteria (9 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
- Abuse or intake of alcohol, defined as any of the below:
- Abuse or intake of drugs, defined as any of the below:
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 |
|---|---|---|
| Semaglutide B, 1.34 mg/mLSubjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously. | Drug | Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL |
| Semaglutide D, 1.0 mg/mLSubjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously. | Drug | Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL |
| Semaglutide D, 1.0 mg/mLSubjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously. | Drug | Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL |
| Semaglutide B, 1.34 mg/mLSubjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously. | Drug | Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL |
Primary outcome
AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in h*nmol/L
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in nmol/L
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 26 Jan 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 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 B, 1.34 mg/mL and Semaglutide D, 1.0 mg/mL in people with Healthy Volunteers (Diabetes Mellitus, Type 2), 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 3 inclusion and 9 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 26 Jan 2024. 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. 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?
AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg (time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg). 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 26 Jan 2024.