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

Consorci Sanitari Integral

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Treated With Insulin

Treatments: Drug: premixed insulin therapy; Drug: basal bolus insulin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04739241

14/11

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Exclusion criteria

• Severe insulin-resistance
• High doses of corticosteroids
• Chemotherapy treatment
• High comorbidity
• Bad compliance of the treatment
• Frequent severe hypoglycaemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A (experimental arm)

Experimental group

Description:

Premixed insulin therapy

Treatment:

Drug: premixed insulin therapy

Group B (active comparator)

Active Comparator group

Description:

Basal bolus insulin therapy

Treatment:

Drug: basal bolus insulin therapy