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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003048-66 | EudraCT Number | ||
| U1111-1132-1018 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| Dose level 2 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| Dose level 3 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| Dose level 4 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| Dose level 5 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin 287 | Drug | Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | As recorded from trial product administration and until completion of Sub-visit 2G (Day 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration-time curve | From 0 to 648 hours after a single dose | |
| Area under the glucose infusion rate (GIR)-time curve | From 0 to 24 hours after a single dose |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| Dose level 6 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| Dose level 7 | Experimental | Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. |
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| insulin glargine | Drug | Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. |
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| placebo | Drug | Oral placebo adminstered corresponding to insulin 287 treatment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |