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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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%).
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
Change in HbA1c levels
Change from baseline in HbA1c levels after 12 months of therapy
Time frame: 12 months after recruitment
Incidence of hypoglycaemia as an adverse effect of the treatment
Number of hypoglycaemias by month
Time frame: every month during the 12-month follow-up
Incidence of dosing errors as a measure of the safety of the treatment
Number of dosing errors by month
Time frame: 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.
Time frame: 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
Time frame: 12-month follow-up
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