Trial | NCT04739241  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Jan 24
2014
Primary Completion
Apr 20
2018
Study Completion
Jun 19
2018
Last Update
Feb 04
2021

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%).

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

Group A (experimental arm) Experimental

Premixed insulin therapy

Group B (active comparator) Active Comparator

Basal bolus insulin therapy

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
No Results Posted