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

Type 2 Diabetes Treated With Insulin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739241
• Other study ID #: 14/11
• Status: Completed
• Phase: Phase 4
• Start date: January 24, 2014
• Est. completion date: June 19, 2018

Study information

• Verified date: June 2018
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 19, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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%).
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c levels	Change from baseline in HbA1c levels after 12 months of therapy	12 months after recruitment
Secondary	Incidence of hypoglycaemia as an adverse effect of the treatment	Number of hypoglycaemias by month	every month during the 12-month follow-up
Secondary	Incidence of dosing errors as a measure of the safety of the treatment	Number of dosing errors by month	every month during the 12-month follow-up
Secondary	Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.	Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes.	12-month follow-up
Secondary	Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.	Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients	12-month follow-up