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This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novolet® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic human insulin 30 | Drug | Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting blood glucose (FBG) | ||
| Change in 2-hour post prandial blood glucose | ||
| Change in HbA1c (glycosylated haemoglobin) | ||
| Change in prandial glucose increment (PGI) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of minor and major hypoglycaemia | ||
| Occurrence of Adverse Drug Reactions (ADR) |
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Inclusion Criteria:
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Subjects with type 2 diabetes not achieving adequate control and being prescribed Mixtard® 30 Novolet® either as a single treatment or in combination with oral hypoglycaemic agents (OHAs).
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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 | Jakarta | 12520 | Indonesia |
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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 |
|---|---|
| C575870 | biphasic human insulin 30 |
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