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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003046-32 | EudraCT Number | ||
| U1111-1132-0943 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin 338 + placebo | Experimental |
| |
| Insulin glargine + placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin 338 (GIPET I) | Drug | Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration-time curve | During one dosing interval (0-24 hours) at steady-state (Day 10) | |
| Area under the glucose infusion rate-time curve | During one dosing interval (0-24 hours) at steady state (Day 10) |
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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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| placebo | Drug | S.c placebo administered in combination with insulin 338 |
|
| insulin glargine | Drug | Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels. |
|
| placebo | Drug | Oral placebo administered in combination with s.c. insulin glargine |
|
| 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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