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

February 1, 2021 updated by: Consorci Sanitari Integral

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (experimental arm)
Premixed insulin therapy
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%).
Active Comparator: Group B (active comparator)
Basal bolus insulin therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c levels
Time Frame: 12 months after recruitment
Change from baseline in HbA1c levels after 12 months of therapy
12 months after recruitment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari Integral

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2014

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

June 19, 2018

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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