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This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDet + IAsp users |
| ||
| IDet + HI users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 7-point blood glucose variability | ||
| Change in body weight | ||
| Insulin dose |
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Inclusion Criteria:
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Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
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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 | Bratislava | 811 05 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Emil Martinka; Improved Glycemic Control and Weight Loss in Slovakian Patients Switching from NPH to Insulin Detemir; 2049-PO; 69th Scientific Sessions (2009); American Diabetes Association |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin aspart | Drug | Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any |
|
| human soluble insulin | Drug | Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any |
|
| Number of injections |
| Number of hypoglycaemic episodes |
| Number of adverse events |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| 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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