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This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rep + NPH | Experimental |
| |
| NPH | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide | Drug | 2 mg at each main meal |
| |
| insulin NPH |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin) | Week 0 (visit 5); week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| FPG (fasting plasma glucose) | Week 0 (visit 5); week 26 | |
| 7-point blood glucose profile | Week 0 (visit 5); week 26 | |
| Hypoglycaemic episodes |
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Inclusion 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 | Shatin, New Territories | Hong Kong | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15983336 | Result | Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Drug |
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner. |
|
| Week 0 (visit 5); week 26 |
| Adverse events | Week 0 (Visit 5); week 26 |
| Kota Bharu, Kelantan |
| 16150 |
| Malaysia |
| Novo Nordisk Investigational Site | Marikina City | 1800 | Philippines |
| Novo Nordisk Investigational Site | Pasig | 1605 | Philippines |
| Novo Nordisk Investigational Site | Quezon City | 1100 | Philippines |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2193 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Novo Nordisk Investigational Site | Brits | North West | 0250 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7460 | South Africa |
| Novo Nordisk Investigational Site | Alberton | 1449 | South Africa |
| Novo Nordisk Investigational Site | Tainan | 710 | Taiwan |
| 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 |
|---|---|
| C072379 | repaglinide |
| D007336 | Insulin, Isophane |
| 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 |
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