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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-9152 | Other Identifier | WHO |
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This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repaglinide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide | Drug | The dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes | weeks 0-26 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | week 13 and 26 | |
| Incidence of Adverse Events (AEs) | week 13 and 26 | |
| Incidence of Serious Adverse Event (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD (thiazolidinedione) and will be additionally prescribed with insulin analogue at the discretion of the physicians will be eligible for this study.
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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 |
|---|---|---|---|---|---|---|
| Seoul | 137-920 | South Korea |
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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 |
|---|---|
| C072379 | repaglinide |
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| week 13 and 26 |
| Change in HbA1c | after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy |