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This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Start dose and frequency at the discretion of the physician following clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | at baseline visit and during 3, 6, 9 and 12 months | |
| Serious adverse drug reactions including major hypoglycaemic events | during 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse drug reactions | during 12 months of treatment | |
| Number of all major (daytime and nocturnal) hypoglycaemic events | during 12 months of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.
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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 | Moscow | 119330 | Russia | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 30 | Drug | Start dose and frequency at the discretion of the physician following clinical practice |
|
| insulin aspart | Drug | Start dose and frequency at the discretion of the physician following clinical practice |
|
| Number of all minor (daytime and nocturnal) hypoglycaemic events |
| During 4 weeks prior to each study visit |
| Weight (BMI) change | At 6 and 12 months |
| Variability in fasting blood glucose values and average (mean) fasting blood glucose level | At baseline visit and after 6 and 12 months treatment |
| Average post-prandial blood glucose level (2h after dinner) | At baseline visit and after 6 and 12 months treatment |
| Quality of Life (QoL) as assessed by patient questionnaire | At baseline and the end of 6 and 12 months treatment |
| Kiev |
| 252030 |
| Ukraine |
| 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 |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D061267 | Insulin Aspart |
| 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 |
| D061266 | Insulin, Short-Acting |
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