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This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soluble human insulin | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major hypoglycaemic episodes | during 26 weeks of insulin therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and type of hypoglycaemic episodes | during 26 weeks of insulin therapy | |
| Frequency and type of adverse events | during 26 weeks of insulin therapy | |
| Frequency and type of adverse drug reactions |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetic patients
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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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| biphasic human insulin | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| insulin NPH | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| insulin aspart | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| biphasic insulin aspart | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| insulin detemir | Drug | Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| during 26 weeks of insulin therapy |
| Change in HbA1c from baseline | during 26 weeks of insulin therapy |
| Change in PPG from baseline | during 26 weeks of insulin therapy |
| Change in FPG from baseline | during 26 weeks of insulin therapy |
| Subjects' insulin treatment satisfaction | during 26 weeks of insulin therapy |
| Physicians' satisfaction with insulin therapy | during 26 weeks of insulin therapy |
| Weight change | at the end of the study |
| Percentage of patients reaching the target of HbA1c less than 7.5% | at the end of the study |
| Percentage of patients reaching the target of HbA1c less than 7% | at the end of the study |
| Percentage of patients reaching the target of HbA1c less than 6.5% | at the end of the study |
| 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 |
|---|---|
| D007328 | Insulin |
| C575870 | biphasic human insulin 30 |
| D007336 | Insulin, Isophane |
| D061267 | Insulin Aspart |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| 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 |
| D049528 | Insulin, Long-Acting |
| D061266 | Insulin, Short-Acting |
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