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This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 users |
| ||
| IDet users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Prescribed at the discretion of the physician |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching HbA1c target of maximum 7.0% | ||
| Postprandial plasma glucose (PPG) | ||
| Fasting plasma glucose (FPG) |
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Inclusion Criteria:
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Macedonian people with diabetes mellitus (Type 1 or Type 2)
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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 | Skopje | MK-1000 | North Macedonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin detemir |
| Drug |
Prescribed at the discretion of the physician |
|
| Change in body weight |
| Incidence of adverse events |
| 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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