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The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (experimental arm) | Experimental | Premixed insulin therapy |
|
| Group B (active comparator) | Active Comparator | Basal bolus insulin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| premixed insulin therapy | Drug | Premixed insulin treatment: 30% of the calculated dose was administered before breakfast and before lunch (biphasic insulin lispro 50% or biphasic insulin aspart 50%) and the remaining 40% of the dose before dinner (biphasic insulin lispro 25% or biphasic insulin aspart insulin 30%). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c levels | Change from baseline in HbA1c levels after 12 months of therapy | 12 months after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoglycaemia as an adverse effect of the treatment | Number of hypoglycaemias by month | every month during the 12-month follow-up |
| Incidence of dosing errors as a measure of the safety of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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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|
| basal bolus insulin therapy | Drug | Basal-bolus insulin treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals |
|
Number of dosing errors by month
| every month during the 12-month follow-up |
| Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12. | Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes. | 12-month follow-up |
| Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12. | Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients | 12-month follow-up |
| D004700 | Endocrine System Diseases |