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This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | |||
| insulin NPH | Drug | |||
| insulin aspart | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after a two-year trial period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | ||
| Body weight | ||
| Antibodies |
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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 | Buenos Aires | Argentina | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18387078 | Result | Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x. | |
| 19545216 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Body composition |
| Blood glucose |
| Hypoglycaemia |
| Ciudad Autonoma de Bs As |
| C1405CWB |
| Argentina |
| Novo Nordisk Investigational Site | Ciudad Autónoma de BsAs | C1406FWY | Argentina |
| Novo Nordisk Investigational Site | Mar del Plata | B7602CBM | Argentina |
| Novo Nordisk Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Novo Nordisk Investigational Site | Hobart | Tasmania | 7000 | Australia |
| Novo Nordisk Investigational Site | Melbourne | Victoria | 3004 | Australia |
| Novo Nordisk Investigational Site | Darlinghurst | 2010 | Australia |
| Novo Nordisk Investigational Site | Melbourne | 3000 | Australia |
| Novo Nordisk Investigational Site | Stones Corner | 4120 | Australia |
| Novo Nordisk Investigational Site | Woodville | 5011 | Australia |
| Novo Nordisk Investigational Site | Plovdiv | 4002 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1431 | Bulgaria |
| Novo Nordisk Investigational Site | Zagreb | 10 000 | Croatia |
| Novo Nordisk Investigational Site | Vellore | Tamil Nadu | 632004 | India |
| Novo Nordisk Investigational Site | Chennai | 600-013 | India |
| Novo Nordisk Investigational Site | Hyderabad | 600034 | India |
| Novo Nordisk Investigational Site | Mumbai | 400 0067 | India |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Bucharest | 020042 | Romania |
| Novo Nordisk Investigational Site | Bucharest | 020475 | Romania |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2193 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 27 11 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 27 21 | South Africa |
| Novo Nordisk Investigational Site | Bloemfontein | 27 51 | South Africa |
| Novo Nordisk Investigational Site | Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34390 | Turkey (Türkiye) |
| Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344. |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| D061267 | Insulin Aspart |
| 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 |
| D061266 | Insulin, Short-Acting |
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