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This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
| ||
| B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines |
| Measure | Description | Time Frame |
|---|---|---|
| Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. | during 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | at the end of the study | |
| FBG (Fasting Blood Glucose) | at the end of the study | |
| Average (mean) fasting plasma glucose level |
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Inclusion Criteria:
Exclusion Criteria:
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Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Manila | 1605 | Philippines |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| insulin detemir | Drug | Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines |
|
| at the end of the study |
| Number of minor (including nocturnal) hypoglycaemic events | during 12 months of treatment |
| Number of major (including nocturnal) hypoglycaemic events | during 12 months of treatment |
| 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 |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| 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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