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This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal/bolus regimen 1 | Experimental |
| |
| Basal/bolus regimen 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-subject variation in home measured blood glucose (3-point blood glucose profiles) | ||
| 8-point blood glucose profiles | ||
| Incidence of self-recorded hypoglycaemic episodes |
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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 | Junín | Argentina | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15298338 | Result | Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin aspart | Drug | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
|
| insulin NPH | Drug | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
|
| human soluble insulin | Drug | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
|
| Incidence of adverse events |
| Morón |
| Argentina |
| Novo Nordisk Investigational Site | Varaždin | 42 000 | Croatia |
| Novo Nordisk Investigational Site | Hradec Králové | 50036 | Czechia |
| Novo Nordisk Investigational Site | Liberec | 46001 | Czechia |
| Novo Nordisk Investigational Site | Plzen - Lochotin | 30460 | Czechia |
| Novo Nordisk Investigational Site | Prague | 10034 | Czechia |
| Novo Nordisk Investigational Site | Prague | 12000 | Czechia |
| Novo Nordisk Investigational Site | Prague | 140 00 | Czechia |
| Novo Nordisk Investigational Site | Prague | 150 18 | Czechia |
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark |
| Novo Nordisk Investigational Site | Copenhagen | 2400 | Denmark |
| Novo Nordisk Investigational Site | Hillerød | 3400 | Denmark |
| Novo Nordisk Investigational Site | Hjørring | 9800 | Denmark |
| Novo Nordisk Investigational Site | Holbæk | 4300 | Denmark |
| Novo Nordisk Investigational Site | Køge | 4600 | Denmark |
| Novo Nordisk Investigational Site | Silkeborg | 8600 | Denmark |
| Novo Nordisk Investigational Site | Slagelse | 4200 | Denmark |
| Novo Nordisk Investigational Site | Svendborg | 5700 | Denmark |
| Novo Nordisk Investigational Site | Kemi | 94100 | Finland |
| Novo Nordisk Investigational Site | Kokkola | 67200 | Finland |
| Novo Nordisk Investigational Site | Kuopio | 70210 | Finland |
| Novo Nordisk Investigational Site | Oulu | FI-90220 | Finland |
| Novo Nordisk Investigational Site | Pärnu | 80010 | Finland |
| Novo Nordisk Investigational Site | Rovaniemi | 96400 | Finland |
| Novo Nordisk Investigational Site | Viljandi | 71024 | Finland |
| Novo Nordisk Investigational Site | Angers | France |
| Novo Nordisk Investigational Site | Grenoble | 38043 | France |
| Novo Nordisk Investigational Site | Lille | 59037 | France |
| Novo Nordisk Investigational Site | Lorient | 56322 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Mougins | 06250 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Paris | 75014 | France |
| Novo Nordisk Investigational Site | Paris | 75475 | France |
| Novo Nordisk Investigational Site | Paris | 75877 | France |
| Novo Nordisk Investigational Site | Poitiers | 86000 | France |
| Novo Nordisk Investigational Site | Athens | GR-10552 | Greece |
| Novo Nordisk Investigational Site | Athens | GR-115 27 | Greece |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Alessandria | Italy |
| Novo Nordisk Investigational Site | Asti | 14100 | Italy |
| Novo Nordisk Investigational Site | Bari | 70100 | Italy |
| Novo Nordisk Investigational Site | Bergamo | 24127 | Italy |
| Novo Nordisk Investigational Site | Catania | 95124 | Italy |
| Novo Nordisk Investigational Site | Catania | 95126 | Italy |
| Novo Nordisk Investigational Site | Genova | 16132 | Italy |
| Novo Nordisk Investigational Site | Lucca | 55100 | Italy |
| Novo Nordisk Investigational Site | Milan | 20132 | Italy |
| Novo Nordisk Investigational Site | Padova | 35143 | Italy |
| Novo Nordisk Investigational Site | Prato | 59100 | Italy |
| Novo Nordisk Investigational Site | Ravenna | 48121 | Italy |
| Novo Nordisk Investigational Site | Roma | 00161 | Italy |
| Novo Nordisk Investigational Site | Torino | 10126 | Italy |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Arendal | 4841 | Norway |
| Novo Nordisk Investigational Site | Gjettum | 1346 | Norway |
| Novo Nordisk Investigational Site | Gjøvik | NO-2819 | Norway |
| Novo Nordisk Investigational Site | Kongsberg | NO-3602 | Norway |
| Novo Nordisk Investigational Site | Kongsvinger | 2212 | Norway |
| Novo Nordisk Investigational Site | Kristiansand | 4604 | Norway |
| Novo Nordisk Investigational Site | Rådal | 5235 | Norway |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-094 | Poland |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-822 | Poland |
| Novo Nordisk Investigational Site | Gdansk | 80-211 | Poland |
| Novo Nordisk Investigational Site | Krakow | 31-501 | Poland |
| Novo Nordisk Investigational Site | Lodz | 90-030 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-718 | Poland |
| Novo Nordisk Investigational Site | Szczecin | 71-455 | Poland |
| Novo Nordisk Investigational Site | Timișoara | 300736 | Romania |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 125315 | Russia |
| Novo Nordisk Investigational Site | Košice | 043 80 | Slovakia |
| Novo Nordisk Investigational Site | Moldava nad Bodvou | 045 01 | Slovakia |
| Novo Nordisk Investigational Site | Falun | 791 82 | Sweden |
| 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 |
| D061267 | Insulin Aspart |
| 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 |
| D061266 | Insulin, Short-Acting |
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