Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes
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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2018
CompletedFirst Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedFebruary 4, 2021
June 1, 2018
4.2 years
January 27, 2021
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c levels
Change from baseline in HbA1c levels after 12 months of therapy
12 months after recruitment
Secondary Outcomes (4)
Incidence of hypoglycaemia as an adverse effect of the treatment
every month during the 12-month follow-up
Incidence of dosing errors as a measure of the safety of the treatment
every month during the 12-month follow-up
Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.
12-month follow-up
Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.
12-month follow-up
Study Arms (2)
Group A (experimental arm)
EXPERIMENTALPremixed insulin therapy
Group B (active comparator)
ACTIVE COMPARATORBasal bolus insulin therapy
Interventions
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 treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe insulin-resistance
- High doses of corticosteroids
- Chemotherapy treatment
- High comorbidity
- Bad compliance of the treatment
- Frequent severe hypoglycaemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 4, 2021
Study Start
January 24, 2014
Primary Completion
April 20, 2018
Study Completion
June 19, 2018
Last Updated
February 4, 2021
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share