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Diabetes Mellitus, Type 2Phase 1NCT03638778

Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

A Phase 1 study testing Semaglutide 3 mg, Semaglutide 7 mg and Semaglutide B 3 mg in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Read more about this study

Who is it for?
Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide 3 mg, Semaglutide 7 mg and Semaglutide B 3 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteGermany
Study dates
17 Aug 2018to 5 Dec 2018
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive). - Considered to be generally healthy 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. Exclusion Criteria: - 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: a) Smoking more than 5 cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - History* of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. - Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma*. - History* or presence of pancreatitis (acute or chronic). *As declared by subject.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novo Nordisk Investigational Site

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Being tested
Semaglutide 3 mg, Semaglutide 7 mg, Semaglutide B 3 mg, Semaglutide B 7 mg, Semaglutide C 3 mg
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.

  • Semaglutide 3 mgDrug

    Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.

  • Semaglutide 7 mgDrug

    Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.

  • Semaglutide B 3 mgDrug

    Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.

  • Semaglutide B 7 mgDrug

    Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.

  • Semaglutide C 3 mgDrug

    Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.

  • Semaglutide C 7 mgDrug

    Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.

  • Semaglutide D 3 mgDrug

    Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.

  • Semaglutide D 7 mgDrug

    Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Study groups in NCT03638778
Study groupRoleWhat they receive
Oral semaglutide (reference)Active comparatorParticipants will receive oral semaglutide (reference) for 10 days.
Receives: Drug: Semaglutide 3 mg; Drug: Semaglutide 7 mg
Oral semaglutide formulation BExperimentalParticipants will receive oral semaglutide formulation B for 10 days.
Receives: Drug: Semaglutide B 3 mg; Drug: Semaglutide B 7 mg
Oral semaglutide formulation CExperimentalParticipants will receive oral semaglutide formulation C for 10 days.
Receives: Drug: Semaglutide C 3 mg; Drug: Semaglutide C 7 mg
Oral semaglutide formulation DExperimentalParticipants will receive oral semaglutide formulation D for 10 days.
Receives: Drug: Semaglutide D 3 mg; Drug: Semaglutide D 7 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing

    Calculated based on semaglutide measured in blood.

    Measured: 0 to 24 hours on day 10

Secondary outcomes (5)

  1. Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

    Calculated based on semaglutide measured in blood.

    Measured: 0 to 24 hours on day 10

  2. tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

    Calculated based on semaglutide measured in blood.

    Measured: 0 to 24 hours on day 10

  3. AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing

    Calculated based on semaglutide measured in blood.

    Measured: 0 to 30 minutes on day 10

  4. t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing

    Calculated based on semaglutide measured in blood. Measured from the 10th. dosing (on Day 10) and up to 35 days after the 10th. dosing (i.e. Day 45).

    Measured: Days 10-45

  5. Number of treatment emergent adverse events

    Count of events.

    Measured: Days 1-47

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start17 Aug 2018
  3. Primary completion5 Dec 2018
  4. Study completion5 Dec 2018

Resources

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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03638778
Sponsor's protocol ID
NN9924-4427
Other IDs
U1111-1206-6210, 2017-005023-24, 2017
Status last verified
Nov 2019
First submitted
8 Aug 2018
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide 3 mg, Semaglutide 7 mg and Semaglutide B 3 mg 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?

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 14 Nov 2019. 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?

AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing (time frame: 0 to 24 hours on day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03638778.

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 14 Nov 2019.

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Clinical Trial NCT03638778 | AzTrials