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

Phase 4

Completed

• Conditions: Type 2 Diabetes Treated With Insulin
• Interventions: Drug: premixed insulin therapy; Drug: basal bolus insulin therapy

• Registration Number: NCT04739241
• Lead Sponsor: Consorci Sanitari Integral

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-24
• Primary Completion: 2018-04-20
• Status Verified: 2018-06
• Study Completion: 2018-06-19
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (experimental arm)	premixed insulin therapy	Premixed insulin therapy
Group B (active comparator)	basal bolus insulin therapy	Basal bolus insulin therapy

Primary Outcome Measures

Name	Time	Method
Change in HbA1c levels	12 months after recruitment	Change from baseline in HbA1c levels after 12 months of therapy

Secondary Outcome Measures

Name	Time	Method
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
Incidence of hypoglycaemia as an adverse effect of the treatment	every month during the 12-month follow-up	Number of hypoglycaemias 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.
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