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This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
| ||
| B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soluble human insulin | Drug | Observational study; use of the products as in the normal clinical practice conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of major hypoglycaemic events reported as serious adverse drug reactions | after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious and non serious drug reactions | during 26 weeks | |
| Number of serious adverse event | during 26 weeks | |
| Number of all major (daytime and nocturnal) hypoglycaemic events |
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Inclusion Criteria:
Exclusion Criteria:
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Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Rome | 00144 | Italy |
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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 |
|---|---|
| D007328 | Insulin |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| biphasic insulin aspart | Drug | Observational study; use of the products as in the normal clinical practice conditions |
|
| during 26 weeks |
| Number of major hypoglycaemic events related to omission of a meal after injection | during 26 weeks |
| Number of major hypoglycaemic events related to physical exercise of at least 30 min duration | during 26 weeks |
| Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit | after 26 weeks |
| Weight and waist circumference change | during 26 weeks |
| Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level | after 26 weeks |
| Quality of Life (QoL) | after 26 weeks |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |