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

Sponsor

Consorci Sanitari Integral (Other)

Overall Status

Completed

CT.gov ID

NCT04739241

Collaborator

(none)

Enrollment

Arms

52.8

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Treated With Insulin	Drug: premixed insulin therapy Drug: basal bolus insulin therapy	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 24, 2014

Actual Primary Completion Date :

Apr 20, 2018

Actual Study Completion Date :

Jun 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (experimental arm) Premixed insulin therapy	Drug: premixed 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%).
Active Comparator: Group B (active comparator) Basal bolus insulin therapy	Drug: basal bolus insulin therapy 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

Arm

Intervention/Treatment

Experimental: Group A (experimental arm)

Premixed insulin therapy

Drug: premixed 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%).

Active Comparator: Group B (active comparator)

Basal bolus insulin therapy

Drug: basal bolus insulin therapy

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

Outcome Measures

Primary Outcome Measures

Change in HbA1c levels [12 months after recruitment]
Change from baseline in HbA1c levels after 12 months of therapy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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