Type 2 Diabetes Treated With Insulin
Conditions
Keywords
premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes, elderly
Brief summary
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.
Interventions
DRUGpremixed insulin therapy
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
Sponsors
Consorci Sanitari Integral
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients * Age ≥ 65 years old * Type 2 diabetes mellitus * HbA1c ≥9% (74 mmol/mol) * Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents
Exclusion criteria
* Severe insulin-resistance * High doses of corticosteroids * Chemotherapy treatment * High comorbidity * Bad compliance of the treatment * Frequent severe hypoglycaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c levels | 12 months after recruitment | Change from baseline in HbA1c levels after 12 months of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoglycaemia as an adverse effect of the treatment | every month during the 12-month follow-up | Number of hypoglycaemias by month |
| Incidence of dosing errors as a measure of the safety of the treatment | every month during the 12-month follow-up | Number of dosing errors by month |
| Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12. | 12-month follow-up | Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes. |
| Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12. | 12-month follow-up | Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients |
Outcome results
None listed