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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-R070015 | Registry Identifier | JAPIC |
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This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCGIR, area under the glucose infusion rate value curve | ||
| GIRmax, the maximum GIR value | ||
| tmax GIR, time to maximum GIR value |
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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 | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Irie S, Matsumura Y, Hirano K. Pharmacokinetics and Pharmacodynamics of Single Dose Insulin Detemir, Long-acting soluble insulin analogue compared to NPH insulin in Patients with type 1 Diabetes Mellitus. Journal of Clinical Ther. and Med. 2007; 5 (23): 349-356 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin NPH | Drug | Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days |
|
| Cmax, maximum concentration |
| Area under the curve |
| tmax, time to maximum concentration |
| MRT, mean residence time |
| t½, terminal half-life |
| Adverse events |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |