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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005147-27 | EudraCT Number | ||
| U1111-1125-2969 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.
The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, level 1-7 escalating doses | Experimental |
| |
| Part 2, cross-over | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0148-0000-0362 | Drug | Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration-time curve (with Trial part 1) | From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively | |
| Area under the glucose infusion rate (GIR)-time curve (Trial part 1) |
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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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin glargine | Drug | As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group |
|
| placebo | Drug | Subjects will receive a single dose of oral placebo within each dose group |
|
| NNC 0148-0000-0362 | Drug | Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period |
|
| NNC 0148-0000-0362 | Drug | Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period |
|
| NNC 0148-0000-0362 | Drug | Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period |
|
| From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively |
| Area under the serum insulin concentration-time curve (Trial part 2) | From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively |
| 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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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