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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002893-30 | EudraCT Number | ||
| U1111-1131-8724 | Other Identifier | WHO |
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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 (NNC0113-0987) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC (dosing condition) | Experimental | Escalation design. |
|
| Oral A | Experimental | Escalation design. Planned end-dose is 5 mg. |
|
| Oral B | Experimental | Escalation design. Planned end-dose is 10 mg. |
|
| Oral C | Experimental | Escalation design. Planned end-dose is 20 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-0987 | Drug | Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) recorded | From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NNC0113-0987 plasma concentration curve | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) | |
| Maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 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 |
|---|---|---|---|---|---|---|
| Harrow | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Once-daily doses for oral administration |
|
| Time to maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) |
| Change in fasting plasma glucose (FPG) | From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) |
| Change in HbA1C (glycosylated haemoglobin) | From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) |
| Change in body weight | From baseline (Day -1) to after 10 weeks of treatment (Day 70) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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