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This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.
Inclusion criteria:
Patients must meet all of the following criteria:
After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active titration algorithm | Active Comparator | titrate insulin dose by contacting with investigator by telephone weekly. |
|
| Usual titration algorithm | Experimental | contact with investigator only at routine study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active titration algorithm | Behavioral | Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl). |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the change in HbA1c between two study groups at Week 24. | compare the change in HbA1c between two study groups after 24 weeks treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the change in HbA1C between two study groups at Week 12. | compare the change in HbA1C between two study groups after 12 of treatment. | 12 weeks |
| To compare the proportion of patients achieving HbA1C <7% at Week 24 |
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Inclusion Criteria:
Patients must meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Chen Liu, MD | Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital | Study Chair |
| Hui-Fang Chang, MD | Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch | Principal Investigator |
| Ke-Yan Wu, MD | Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch | Hsinchu | 30067 | Taiwan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual titration algorithm | Behavioral | All patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL. |
|
|
compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
| 24 weeks |
| To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24. | compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment. | 24 weeks |
| To compare the change in body weight at each visit | compare the change in body weight at each visit | 24 weeks |
| To evaluate the incidence of adverse events. | evaluate the incidence of adverse events including hypoglycemia and any other adverse event. | 24 weeks |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch | Taitung | 95054 | Taiwan |
| D004700 | Endocrine System Diseases |