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This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
| ||
| B |
| ||
| C |
|
| 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 |
|---|---|---|
| Incidence of major hypoglycaemic events reported | during 24 weeks of treatment | |
| Change in HbA1c | during 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving HbA1c below 7.0% | at 12 & 24 weeks | |
| Change in FPG | at 12 & 24 weeks | |
| Change in PPG |
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Inclusion Criteria:
Exclusion Criteria:
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A non-randomized sample of Type 1 or Type 2 diabetics
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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 | Riyadh | 3542 | Saudi Arabia |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 30 | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| insulin aspart | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| at 12 & 24 weeks |
| Body weight | at 12 & 24 weeks |
| Change in number of hypoglycaemic events in the last 4 weeks before routine visits | at 12 & 24 weeks |
| Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits | at 12 & 24 weeks |
| Number of adverse drug reactions (ADR) | at 12 & 24 weeks |
| 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 |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| 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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