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The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin detemir | Experimental |
| |
| NPH insulin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin detemir | Drug |
| ||
| NPH insulin |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the level of glycosylated haemoglobin(HbA1c) | From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Broadmeadow | New South Wales | 2292 | Australia | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15220016 | Result | Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0. |
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According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com
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|
| Ashford |
| 5035 |
| Australia |
| Novo Nordisk Investigational Site | Box Hill | 3128 | Australia |
| Novo Nordisk Investigational Site | Clayton | 3168 | Australia |
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| Novo Nordisk Investigational Site | Abergavenny | NP7 7EG | United Kingdom |
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| Novo Nordisk Investigational Site | Glasgow | G4 0SF | United Kingdom |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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