Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial

Conditions
-----------------
Type 2 Diabetes Treated With Insulin

Intervention / Treatment
-----------------
* Drug: premixed insulin therapy
* Drug: basal bolus insulin therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (experimental arm)<br>Premixed insulin therapy | Drug: premixed insulin therapy<br>* 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%).<br>|
| Active Comparator: Group B (active comparator)<br>Basal bolus insulin therapy | Drug: basal bolus insulin therapy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels | Change from baseline in HbA1c levels after 12 months of therapy | 12 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes