DiabetesPhase 1NCT02231684
Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
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 investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide. 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
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Jan 2015
- 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 male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
- Age between 18 and 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
- Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Centre, Two Period, Incomplete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.
- Being tested
- semaglutide
- 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
Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).
semaglutideDrug
Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Not described Receives: Drug: semaglutide |
| s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml) | Experimental | 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 semaglutide plasma concentration curve
Measured: From day 0-day 35/840 hours
Secondary outcomes (3)
Maximum observed semaglutide plasma concentration
Measured: From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths
Area under the semaglutide plasma concentration-time curve
Measured: From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)
Number of treatment emergent adverse events (TEAEs)
Measured: From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- 42 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
- NCT02231684
- Sponsor's protocol ID
- NN9535-3687
- Other IDs
- 2013-004566-34, U1111-1149-3980
- Status last verified
- Jan 2015
- First submitted
- 29 Aug 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Centre, Two Period, Incomplete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
- ClinicalTrials.gov ID
- NCT02231684
- Acronym / sponsor ID
- NN9535-3687
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Sep 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 Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Drug: semaglutide |
| i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml) | Experimental | Drug: semaglutide |
| s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml) | Experimental | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
- Age between 18 and 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive)
Key exclusion criteria (6 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL 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 |
|---|---|---|
| semaglutideSemaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL). | Drug | s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml), s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml), s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml), s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml), s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml), s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml) |
| semaglutideSemaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL). | Drug | i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml), s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml) |
Primary outcome
Area under the semaglutide plasma concentration curve
Time frame: From day 0-day 35/840 hours
3 secondary outcomes
Maximum observed semaglutide plasma concentration
Time frame: From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths
Area under the semaglutide plasma concentration-time curve
Time frame: From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)
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 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 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 3 inclusion and 6 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 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 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 semaglutide plasma concentration curve (time frame: From day 0-day 35/840 hours). 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 2015.