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This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | The insulin dose and regimen was individualised at the physician's discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in post prandial glucose (PPG) | ||
| Change in fasting glucose (FG) | ||
| Difference in prandial glucose increment (PGI) |
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Inclusion Criteria:
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Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)
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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 | Seoul | 137-920 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19684847 | Result | Guler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x. | |
| 18269636 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Incidence of hypoglycaemic episodes |
| Adverse drug reactions (ADR) |
| Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, Shestakova M, Ayad NM, Guler S, Bech OM; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008 Mar;10(3):212-22. doi: 10.1111/j.1463-1326.2007.00826.x. |
| 18005503 | Result | Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, Danciulescu R, Khutsoane D, Guler S. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007 Dec;23(12):3209-14. doi: 10.1185/030079907X253636. |
| 18494806 | Result | Gao Y, Guo XH, Vaz JA; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009 Jan;11(1):33-40. doi: 10.1111/j.1463-1326.2008.00904.x. Epub 2008 May 20. |
| 18479365 | Result | Jang HC, Guler S, Shestakova M; PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008 Jul;62(7):1013-8. doi: 10.1111/j.1742-1241.2008.01792.x. Epub 2008 May 9. |
| 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 |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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