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This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.
Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight and BMI | during 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight at different BMI subgroups | at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment | |
| Change in waist perimeter | from insulin start and after 6 and 12 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.
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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 |
|---|---|---|---|---|---|---|
| Alphen aan den Rijn | Netherlands | |||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Change in FPG (Fasting Plasma Glucose) | from 12 and 6 months before treatment after 6 and 12 months of treatment |
| Change in HbA1C | from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment |
| Change in number of hypoglycaemic events during 4 weeks proceeding routine visits | after 6 and 12 months of treatment |
| Number of adverse drug reactions (ADR) | after 6 and 12 months of treatment |
| Change in blood pressure | from insulin start and 6 and 12 months after treatment |
| Ljubljana |
| SI-1000 |
| Slovenia |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |