DiabetesPhase 1NCT01766245
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
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 the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes. 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?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to May 2013
- 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
- Healthy subjects
- Body mass index (BMI) of 18.5-30 kg/m^2 (both incl.)
Who cannot join
- History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
- Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- Smoking, drug or alcohol abuse
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.
- Being tested
- semaglutide
- Keywords
- mm
- 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
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.
| Study group | Role | What they receive |
|---|---|---|
| Formulation A followed by Formulation B | Experimental | Not described Receives: Drug: semaglutide |
| Formulation B followed by Formulation A | Active comparator | Not described Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma semaglutide concentration curve
Measured: 0-4 weeks after a single dose s.c. semaglutide administration
Cmax, the maximum plasma semaglutide concentration
Measured: 20-40 hours after a single dose s.c. semaglutide administration
Secondary outcomes (5)
The area under the plasma semaglutide concentration curve
Measured: From time 0 to infinity after a single dose s.c. semaglutide administration
tmax, time to Cmax of semaglutide
Measured: 20-40 hours
t½, terminal elimination half-life of semaglutide
Measured: 140-200 hours
Incidence of adverse events (AEs)
Measured: From first dosing to follow-up (5-7 weeks after the second dosing)
Hypoglycaemic episodes
Measured: From first dosing to follow-up (5-7 weeks after the second dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT01766245
- Sponsor's protocol ID
- NN9535-4010
- Other IDs
- 2012-002212-20, U1111-1130-3931
- Status last verified
- Jun 2014
- First submitted
- 19 Dec 2012
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
- ClinicalTrials.gov ID
- NCT01766245
- Acronym / sponsor ID
- NN9535-4010
- Keywords
- mm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jan 2013 (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 the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A followed by Formulation B | Experimental | Drug: semaglutide |
| Formulation B followed by Formulation A | Active comparator | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Body mass index (BMI) of 18.5-30 kg/m^2 (both incl.)
Key exclusion criteria (4 listed)
- History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
- Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- Smoking, drug or alcohol abuse
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide
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 |
|---|---|---|
| semaglutideFor subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits. | Drug | Formulation A followed by Formulation B, Formulation B followed by Formulation A |
Primary outcome
Area under the plasma semaglutide concentration curve
Time frame: 0-4 weeks after a single dose s.c. semaglutide administration
Cmax, the maximum plasma semaglutide concentration
Time frame: 20-40 hours after a single dose s.c. semaglutide administration
5 secondary outcomes
The area under the plasma semaglutide concentration curve
Time frame: From time 0 to infinity after a single dose s.c. semaglutide administration
tmax, time to Cmax of semaglutide
Time frame: 20-40 hours
t½, terminal elimination half-life of semaglutide
Time frame: 140-200 hours
Incidence of adverse events (AEs)
Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)
Hypoglycaemic episodes
Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)
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 25 Jun 2014.
- 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 2 inclusion and 4 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 25 Jun 2014. 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?
Area under the plasma semaglutide concentration curve (time frame: 0-4 weeks after a single dose s.c. semaglutide administration). 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 25 Jun 2014.