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This trial is conducted in Europe.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | |||
| insulin NPH | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 26 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | ||
| Within-subject variation | ||
| Incidence of total 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 | Arlon | 6700 | Belgium | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16732007 | Result | Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. doi: 10.2337/dc05-1365. | |
| 18715200 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Body weight |
| Incidence of adverse events |
| Insulin antibodies |
| Gilly |
| 6060 |
| Belgium |
| Novo Nordisk Investigational Site | Huy | 4500 | Belgium |
| Novo Nordisk Investigational Site | Jumet | 6040 | Belgium |
| Novo Nordisk Investigational Site | Rijeka | 51 000 | Croatia |
| Novo Nordisk Investigational Site | Zagreb | 10 000 | Croatia |
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark |
| Novo Nordisk Investigational Site | Copenhagen | 2400 | Denmark |
| Novo Nordisk Investigational Site | Hjørring | 9800 | Denmark |
| Novo Nordisk Investigational Site | Hvidovre | 2650 | Denmark |
| Novo Nordisk Investigational Site | Kalundborg | 4400 | Denmark |
| Novo Nordisk Investigational Site | København S | 2300 | Denmark |
| Novo Nordisk Investigational Site | Køge | 4600 | Denmark |
| Novo Nordisk Investigational Site | Slagelse | 4200 | Denmark |
| Novo Nordisk Investigational Site | Amiens | France |
| Novo Nordisk Investigational Site | Auxerre | 89000 | France |
| Novo Nordisk Investigational Site | Avignon | 84902 | France |
| Novo Nordisk Investigational Site | Dax | 40107 | France |
| Novo Nordisk Investigational Site | Évry | 91014 | France |
| Novo Nordisk Investigational Site | Mougins | 06250 | France |
| Novo Nordisk Investigational Site | Nanterre | 92014 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Rueil-Malmaison | 92501 | France |
| Novo Nordisk Investigational Site | Valenciennes | 59322 | France |
| Novo Nordisk Investigational Site | Vénissieux | 69200 | France |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Bekkestua | 1357 | Norway |
| Novo Nordisk Investigational Site | Bergen | NO-5012 | Norway |
| Novo Nordisk Investigational Site | Elverum | 2408 | Norway |
| Novo Nordisk Investigational Site | Gjettum | 1346 | Norway |
| Novo Nordisk Investigational Site | Gjøvik | NO-2819 | Norway |
| Novo Nordisk Investigational Site | Jessheim | 2050 | Norway |
| Novo Nordisk Investigational Site | Oslo | 0370 | Norway |
| Novo Nordisk Investigational Site | Rådal | 5235 | Norway |
| Novo Nordisk Investigational Site | Stavanger | 4011 | Norway |
| Novo Nordisk Investigational Site | Gniewkowo | 88-140 | Poland |
| Novo Nordisk Investigational Site | Krakow | 31-261 | Poland |
| Novo Nordisk Investigational Site | Lodz | 90-030 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-718 | Poland |
| Novo Nordisk Investigational Site | Rawa Mazowiecka | 96-200 | Poland |
| Novo Nordisk Investigational Site | Szczecin | 71-455 | Poland |
| Novo Nordisk Investigational Site | Tychy | 43-100 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 01-809 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 01-877 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-097 | Poland |
| Novo Nordisk Investigational Site | Wołomin | 05-200 | Poland |
| Novo Nordisk Investigational Site | Zabrze | 41-800 | Poland |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 119435 | Russia |
| Novo Nordisk Investigational Site | Moscow | 123448 | Russia |
| Novo Nordisk Investigational Site | Moscow | 127411 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194354 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 198013 | Russia |
| Novo Nordisk Investigational Site | Trenčín | 91171 | Slovakia |
| Novo Nordisk Investigational Site | Falun | 791 82 | Sweden |
| Novo Nordisk Investigational Site | Grästorp | 467 22 | Sweden |
| Novo Nordisk Investigational Site | Kristianstad | 291 85 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 581 85 | Sweden |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Lund | 223 70 | Sweden |
| Novo Nordisk Investigational Site | Trelleborg | 231 85 | Sweden |
| Novo Nordisk Investigational Site | Umeå | 901 85 | Sweden |
| Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282. |
| 33166419 | Derived | Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. |
| 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 |
|---|---|
| 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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