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This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMixĀ® 30 (biphasic insulin aspart 30) or LevemirĀ® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin detemir |
| ||
| Biphasic insulin aspart 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Safety and effectiveness data collection in connection with the use of the drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse drug reactions (SADRs) | after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of all minor hypoglycaemic events | during 4 weeks preceding each visit | |
| Number of all major hypoglycaemic events | during 13 weeks preceding each visit | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment 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 |
|---|---|---|---|---|---|---|
| Skopje | MK-1000 | North Macedonia |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| biphasic insulin aspart 30 | Drug | Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice. |
|
| HbA1c |
| after 26 weeks |
| Percentage of subjects to reach HbA1c below 7.0% | after 13 weeks and 26 weeks |
| The effect on glycaemic control as measured by FPG (fasting plasma glucose) | after 13 weeks and 26 weeks |
| The effect on glycamic control as measured by PG profile | after 13 weeks and 26 weeks |
| Change in body weight | after 13 weeks and 26 weeks |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |