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

NCT ID: NCT04739241

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-24
• Study Completion Date: 2018-06-19

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.

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (experimental arm)

Premixed insulin therapy

Group Type: EXPERIMENTAL

premixed insulin therapy

Intervention Type: DRUG

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%).

Group B (active comparator)

Basal bolus insulin therapy

Group Type: ACTIVE_COMPARATOR

basal bolus insulin therapy

Intervention Type: DRUG

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

Interventions

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%).

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari Integral

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

14/11

Identifier Type: -

Identifier Source: org_study_id