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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003199-38 | EudraCT Number | ||
| U1111-1132-4190 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (single dose) | Experimental |
| |
| Part B (multiple dose) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAEs) | Day -1 to Day 24 | |
| Part B: Number of treatment emergent adverse events (TEAEs) | Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve | From time 0 to 24 hours after a single dose (Day 0) | |
| Part B: AUCÏ„,semaglutide: area under the semaglutide plasma concentration curve | Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 14050 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| semaglutide | Drug | Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts. |
|
| placebo | Drug | In each cohort of 10, eight subjects will randomised to active treatment and two to placebo. |
|
| placebo | Drug | In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C). |
|
| Part B: Change in fasting plasma glucose (FPG) from baseline | Day 0 (pre-dose), day 70 |
| Part B: Change in body weight from baseline | Day -1, day 70 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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