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This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of hypoglycaemic events from baseline | at 12 and 24 weeks | |
| HbA1c | at 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects to reach HbA1c between 6.5 and 7.0% | at 12 and 24 weeks | |
| Glucose variability as measured by FPG | at 12 and 24 weeks | |
| Postprandial glycaemic control as measured by PPG |
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Inclusion Criteria:
Exclusion Criteria:
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Any subject with type 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.
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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 | Kfar Saba | 44425 | Israel | |||
| Novo Nordisk Investigational Site |
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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 |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| at 12 and 24 weeks |
| Insulin dose and number of injections | at 12 and 24 weeks |
| Body weight | at 12 and 24 weeks |
| Number of adverse drug reactions (ADR) | at 12 and 24 weeks |
| Amman |
| 11844 |
| Jordan |
| Novo Nordisk Investigational Site | Amman | 11844 | Lebanon |
| Novo Nordisk Investigational Site | Karachi | Pakistan |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |