Diabetes Mellitus, Type 2Phase 1NCT04524832
Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
A Phase 1 study testing Oral semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
In this study a known investigational medicinal product called semaglutide will be tested in four different tablet versions. In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts. All tablet versions have a helping agent called SNAC. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteGermany
- Study dates
- 29 Sep 2020to 25 Feb 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 21.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below:1) Smoking more than 5 cigarettes or the equivalent per day.2) Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by participant) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by participant).
- Presence or history (as declared by participant) of pancreatitis (acute or chronic).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial Investigating Steady State Semaglutide Exposure of 25 and 50 mg of Oral Semaglutide in Different Formulations in Healthy Subjects
In this study a known investigational medicinal product called semaglutide will be tested in four different tablet versions. In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts. All tablet versions have a helping agent called SNAC. All tablet versions are tested for the treatment of type 2 diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the amount of semaglutide in the blood to be higher than what has been tested before. Further aims of this study are to find an optimal version for the semaglutide tablets, and to examine the safety and tolerability of the different tablet versions. For this purpose, the amount of semaglutide in the blood will be measured after taking different semaglutide tablets, in different doses. The version of the tablet participants will receive (i.e. the treatment arm participants will be assigned to) is decided by chance.
In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks for each period (participants may get 2 tablets per day in treatment period 5). This means that treatment will take 16 weeks in total. The tablets should be taken in the morning together with no more than half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing participants must wait 30-35 minutes before they eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.
No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks) and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic visits with the study doctor. Some of the visits include overnight stays. Participants will have blood tests at every visit. Participants must be healthy and have a body mass index (BMI) between 21.0 and 29.9 kg/m^2 For women: Women cannot take part in this study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral semaglutideDrug
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide D 50 mg | Experimental | Participants will receive once daily semaglutide D formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) Receives: Drug: Oral semaglutide |
| Semaglutide C 50 mg | Experimental | Participants will receive once daily semaglutide C formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) Receives: Drug: Oral semaglutide |
| 2 x Semaglutide C 25 mg | Experimental | Participants will receive once daily semaglutide C formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 2 x 25 mg (week 13-16) Receives: Drug: Oral semaglutide |
| Semaglutide E 50 mg | Experimental | Participants will receive once daily semaglutide tablets in a dose escalating manner for 16 weeks: A) Semaglutide C formulation: 2.4 mg (week 1-2), 5.6 mg (week 3-4) and 11.2 mg (week 5-8). B) Semaglutide E formulation: 25 mg (week 9-12) and 50 mg (week 13-16) Receives: Drug: Oral semaglutide |
| Semaglutide F 50 mg | Experimental | Participants will receive once daily semaglutide F formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) Receives: Drug: Oral semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide plasma concentration - time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
nmol*h/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
nmol*h/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
Secondary outcomes (9)
Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
nmol*h/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56.
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
nmol/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
nmol/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
nmol/L
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)
hour
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)
hour
Measured: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
Number of treatment-emergent adverse events
Count
Measured: From the time of first dosing (visit 2, day 1) until completion of the follow-up visit (visit 11, day 149)
Change in pulse
Beats/minute
Measured: From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)
Change in blood pressure
mmHg
Measured: From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start29 Sep 2020
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524832
- Sponsor's protocol ID
- NN9924-4633
- Other IDs
- U1111-1242-2643, 2019-004157-80, 2019
- Status last verified
- Oct 2023
- First submitted
- 21 Aug 2020
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial Investigating Steady State Semaglutide Exposure of 25 and 50 mg of Oral Semaglutide in Different Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04524832
- Acronym / sponsor ID
- NN9924-4633
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 24 Aug 2020 (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 study a known investigational medicinal product called semaglutide will be tested in four different tablet versions. In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts. All tablet versions have a helping agent called SNAC. All tablet versions are tested for the treatment of type 2 diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the amount of semaglutide in the blood to be higher than what has been tested before. Further aims of this study are to find an optimal version for the semaglutide tablets, and to examine the safety and tolerability of the different tablet versions. For this purpose, the amount of semaglutide in the blood will be measured after taking different semaglutide tablets, in different doses. The version of the tablet participants will receive (i.e. the treatment arm participants will be assigned to) is decided by chance.
In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks for each period (participants may get 2 tablets per day in treatment period 5). This means that treatment will take 16 weeks in total. The tablets should be taken in the morning together with no more than half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing participants must wait 30-35 minutes before they eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.
No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks) and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic visits with the study doctor. Some of the visits include overnight stays. Participants will have blood tests at every visit. Participants must be healthy and have a body mass index (BMI) between 21.0 and 29.9 kg/m^2 For women: Women cannot take part in this study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Semaglutide D 50 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide D formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) |
| Semaglutide C 50 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide C formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) |
| 2 x Semaglutide C 25 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide C formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 2 x 25 mg (week 13-16) |
| Semaglutide E 50 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide tablets in a dose escalating manner for 16 weeks: A) Semaglutide C formulation: 2.4 mg (week 1-2), 5.6 mg (week 3-4) and 11.2 mg (week 5-8). B) Semaglutide E formulation: 25 mg (week 9-12) and 50 mg (week 13-16) |
| Semaglutide F 50 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide F formulation tablets in a dose escalating manner for 16 weeks: 2.4 mg (week 1-2), 5.6 mg (week 3-4), 11.2 mg (week 5-8), 25 mg (week 9-12) and 50 mg (week 13-16) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 21.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (6 listed)
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below:1) Smoking more than 5 cigarettes or the equivalent per day.2) Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by participant) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by participant).
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 |
|---|---|---|
| Oral semaglutideParticipants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 16 weeks | Drug | 2 x Semaglutide C 25 mg, Semaglutide C 50 mg, Semaglutide D 50 mg, Semaglutide E 50 mg, Semaglutide F 50 mg |
Primary outcome
Area under the semaglutide plasma concentration - time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
nmol*h/L
Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
nmol*h/L
9 secondary outcomes
Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56.
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84
Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)
Time frame: From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112
Number of treatment-emergent adverse events
Time frame: From the time of first dosing (visit 2, day 1) until completion of the follow-up visit (visit 11, day 149)
Change in pulse
Time frame: From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)
Change in blood pressure
Time frame: From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)
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 10 Oct 2023.
- 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 Reporting Anchor and Disclosure 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 Oral semaglutide in people with Diabetes Mellitus, Type 2, 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 10 Oct 2023. 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 - time curve during a dosing interval at steady state (AUC0-24h,sema,SS) (time frame: From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84). 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 10 Oct 2023.