DiabetesPhase 1NCT01686945
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, 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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in… 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, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- 19 Sep 2012to 8 Apr 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
- Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m^2. b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m^2
- Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with T2D: between 6.5 and 9.0% (both inclusive)
- Additional inclusion criterion only for subjects with T2D: Male subjects with T2D (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0) and for whom no changes in treatment are planned for the trial period
Who cannot join
- History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Blood pressure in supine position at the screening examination above: a) 140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D
- Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
- Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
- Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60. The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race
- Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
- Clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1) at the discretion of the investigator
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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- semaglutide, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
semaglutideDrug
Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
semaglutideDrug
Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
placeboDrug
Placebo semaglutide. For oral administration.
placeboDrug
Placebo semaglutide with carrier. For oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Healthy - 20 mg | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| Healthy - 40 mg | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| Healthy - 60 mg | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
| T2D - 20/40/60 mg | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs) recorded
Measured: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)
Secondary outcomes (6)
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Measured: After the last 3 daily doses for semaglutide and carrier
Change from baseline in fasting plasma glucose (FPG)
Measured: Week 0, week 10 (Day 69)
Change from baseline in C-peptide
Measured: Week 0, week 10 (Day 69)
Change from baseline in insulin
Measured: Week 0, week 10 (Day 69)
Change from baseline in glucagon
Measured: Week 0, week 10 (Day 69)
Change from baseline in glycosylated haemoglobin type A1c (HbA1c)
Measured: Week 0, week 10 (Day 69)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start19 Sep 2012
- Primary completion8 Apr 2013
- Study completion8 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 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
- NCT01686945
- Sponsor's protocol ID
- NN9924-3991
- Other IDs
- 2012-000361-20, U1111-1127-4408
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2012
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492.
PubMed 30566096Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.
PubMed 30565096
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01686945
- Acronym / sponsor ID
- NN9924-3991
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 8 Apr 2013 (actual)
- Study completion
- 8 Apr 2013 (actual)
- First posted
- 18 Sep 2012 (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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy - 20 mg | Experimental | Drug: semaglutide, Drug: placebo |
| Healthy - 40 mg | Experimental | Drug: semaglutide, Drug: placebo |
| Healthy - 60 mg | Experimental | Drug: semaglutide, Drug: placebo |
| T2D - 20/40/60 mg | Experimental | Drug: semaglutide, Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
- Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m^2. b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m^2
- Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with T2D: between 6.5 and 9.0% (both inclusive)
- Additional inclusion criterion only for subjects with T2D: Male subjects with T2D (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0) and for whom no changes in treatment are planned for the trial period
Key exclusion criteria (7 listed)
- History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Blood pressure in supine position at the screening examination above: a) 140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D
- Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
- Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
- Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60. The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race
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 |
|---|---|---|
| semaglutideStart doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration. | Drug | Healthy - 20 mg |
| semaglutideStart doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration. | Drug | Healthy - 40 mg |
| semaglutideStart doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration. | Drug | Healthy - 60 mg, T2D - 20/40/60 mg |
| placeboPlacebo semaglutide. For oral administration. | Drug | Healthy - 20 mg, Healthy - 40 mg, Healthy - 60 mg, T2D - 20/40/60 mg |
| placeboPlacebo semaglutide with carrier. For oral administration. | Drug | Healthy - 20 mg, Healthy - 40 mg, Healthy - 60 mg, T2D - 20/40/60 mg |
Primary outcome
Number of treatment emergent adverse events (TEAEs) recorded
Time frame: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)
6 secondary outcomes
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Time frame: After the last 3 daily doses for semaglutide and carrier
Change from baseline in fasting plasma glucose (FPG)
Time frame: Week 0, week 10 (Day 69)
Change from baseline in C-peptide
Time frame: Week 0, week 10 (Day 69)
Change from baseline in insulin
Time frame: Week 0, week 10 (Day 69)
Change from baseline in glucagon
Time frame: Week 0, week 10 (Day 69)
Change from baseline in glycosylated haemoglobin type A1c (HbA1c)
Time frame: Week 0, week 10 (Day 69)
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 4 Jan 2019.
- Results publication: PubMed 30566096Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492.
- Derived from this study: PubMed 30565096Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.
- 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 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 4 inclusion and 7 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 4 Jan 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?
Number of treatment emergent adverse events (TEAEs) recorded (time frame: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)). 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 NCT01686945, which also lists 2 linked publications.
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 4 Jan 2019.