Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
| ||
| B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change | at 3 months and 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic events | at 3 months and 6 months after baseline | |
| Changes in glycaemic parameters | at 3 months and 6 months after baseline | |
| Safety parameters by collecting (serious) adverse events and the pregnancies. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Insulin naïve patients with type 2 diabetes treated with oral antidiabetics
Not provided
| 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 | Ljubljana | SI-1000 | Slovenia |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| insulin NPH | Drug | Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician |
|
| at 3 months and 6 months after baseline |
| Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I). | at 3 months and 6 months after baseline |
| Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II) | at 3 months and 6 months after baseline |
| Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III). | at 3 months and 6 months after baseline |
| Changes in doses | at 3 months and 6 months after baseline |
| HbA1c | at 3 months and 6 months after baseline |
| Changes in daily blood glucose values | at 3 months and 6 months after baseline |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |