Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief 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 healthy male subjects and male subjects with type 2 diabetes (T2D).
Interventions
DRUGsemaglutide
Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
DRUGplacebo
Placebo semaglutide. For oral administration.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (TEAEs) recorded | From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose (FPG) | Week 0, week 10 (Day 69) |
| Change from baseline in C-peptide | Week 0, week 10 (Day 69) |
| Area under the plasma concentration curve over the dosing interval (0-24 hours) | After the last 3 daily doses for semaglutide and carrier |
| Change from baseline in glucagon | Week 0, week 10 (Day 69) |
| Change from baseline in glycosylated haemoglobin type A1c (HbA1c) | Week 0, week 10 (Day 69) |
| Change from baseline in insulin | Week 0, week 10 (Day 69) |
Countries
Germany
Outcome results
None listed