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This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin LevemirĀ® under normal clinical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of serious adverse drug reactions, including major hypoglycaemic events | From baseline to 12 and 24 weeks of LevemirĀ® therapy, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events | From baseline to 12 and 24 weeks of LevemirĀ® therapy, respectively | |
| Number of all adverse events | From baseline to 12 and 24 weeks of LevemirĀ® therapy, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before
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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 |
|---|---|---|---|---|---|---|
| Casablanca | 20000 | Morocco |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Number of all hypoglycaemic events | in the 4 weeks preceding the visits at 12 weeks and 24 weeks. |
| Weight changes | at the end of study |
| HbA1c | at the end of study |
| Sub -group analysis of hypo risk | From baseline to 12 and 24 weeks of LevemirĀ® therapy, respectively |
| 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 |
| 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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