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This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | |||
| metformin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose profiles | ||
| Cardiovascular risk factors | ||
| Incidence of hypoglycaemic episodes |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Bloemfontein | Free State | 9301 | South Africa | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Naiker P, Makan HA, Kedijang T, Kong LLL, Omar MAK & the BIAsp-1579 Study Group. Effects of Once-Daily Biphasic Insulin Aspart 30 with Metformin versus Twice-Daily Biphasic Insulin Aspart 30 in South African Type 2 Diabetes Subjects. Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA); Country: South Africa City: Bloemfontein | ||
| Result | Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Effect of biphasic insulin aspart 30/70 (BIAsp30) in combination with metformin on glycaemic control in subjects with type 2 diabetes not optimally controlled on oral antidiabetic agents. EASD 2006 2006; 49(Suppl 1): 599 | ||
| Result | Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Efficacy of biphasic insulin aspart 30/70 with metformin on glycaemic control in poorly-controlled type 2 diabetes. IDF 2006 2006; 23(Suppl 4): 339 (P940) |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Adverse events |
| Johannesburg |
| Gauteng |
| 1827 |
| South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1829 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2001 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | 0116 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Novo Nordisk Investigational Site | Pietermaritzburg | KwaZulu-Natal | 3235 | South Africa |
| Novo Nordisk Investigational Site | Brits | North West | 0250 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7708 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7800 | South Africa |
| Novo Nordisk Investigational Site | Benoni | 1500 | South Africa |
| Novo Nordisk Investigational Site | Bloemfontein | 27 51 | South Africa |
| Novo Nordisk Investigational Site | Kimberley | 8301 | South Africa |
| Novo Nordisk Investigational Site | Richards Bay | 3900 | South Africa |
| 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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