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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
premixed insulin therapy
basal bolus insulin therapy
Sponsored by
Consorci Sanitari Integral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin focused on measuring premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A (experimental arm)

    Group B (active comparator)

    Arm Description

    Premixed insulin therapy

    Basal bolus insulin therapy

    Outcomes

    Primary Outcome Measures

    Change in HbA1c levels
    Change from baseline in HbA1c levels after 12 months of therapy

    Secondary Outcome Measures

    Incidence of hypoglycaemia as an adverse effect of the treatment
    Number of hypoglycaemias by month
    Incidence of dosing errors as a measure of the safety of the treatment
    Number of dosing errors by month
    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.
    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

    Full Information

    First Posted
    January 27, 2021
    Last Updated
    February 1, 2021
    Sponsor
    Consorci Sanitari Integral
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04739241
    Brief Title
    Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 24, 2014 (Actual)
    Primary Completion Date
    April 20, 2018 (Actual)
    Study Completion Date
    June 19, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Consorci Sanitari Integral

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Treated With Insulin
    Keywords
    premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes, elderly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (experimental arm)
    Arm Type
    Experimental
    Arm Description
    Premixed insulin therapy
    Arm Title
    Group B (active comparator)
    Arm Type
    Active Comparator
    Arm Description
    Basal bolus insulin therapy
    Intervention Type
    Drug
    Intervention Name(s)
    premixed insulin therapy
    Intervention Description
    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
    Intervention Name(s)
    basal bolus insulin therapy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in HbA1c levels
    Description
    Change from baseline in HbA1c levels after 12 months of therapy
    Time Frame
    12 months after recruitment
    Secondary Outcome Measure Information:
    Title
    Incidence of hypoglycaemia as an adverse effect of the treatment
    Description
    Number of hypoglycaemias by month
    Time Frame
    every month during the 12-month follow-up
    Title
    Incidence of dosing errors as a measure of the safety of the treatment
    Description
    Number of dosing errors by month
    Time Frame
    every month during the 12-month follow-up
    Title
    Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.
    Description
    Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes.
    Time Frame
    12-month follow-up
    Title
    Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.
    Description
    Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients
    Time Frame
    12-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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