Comparison of Thrice-Daily Premixed Human Insulin with Basal-Bolus Therapy Among Patients with Poorly Controlled Type 2 Diabetes Mellitus
1 other identifier
interventional
44
1 country
1
Brief Summary
The goal of this cross-over study is to learn if thrice-daily (TDS) premixed human insulin (PHI) is as useful as basal-bolus (BB) therapy as an intensification treatment in people with poorly controlled type 2 diabetes mellitus (T2DM). The main questions it aims to answer are:
- To determine the efficacy of TDS PHI compared to BB insulin regimen by measuring HbA1c changes over 12 weeks.
- To determine the changes in fasting plasma glucose (FPG), the total daily dose (TDD) of insulin, weight changes, and hypoglycaemia rate, and to study the adherence rate to insulin injection between the two regimens over 12 weeks. Researchers will compare TDS-PHI to BB regimen to see if the glycemic control, TDD of insulin, weight gain, hypoglycemia and adherence rate are the same. Participants will:
- take TDS-PHI or BB for 12 weeks and cross over to the other regimen for another 12 weeks
- visit the clinic once every 4 weeks for checkups and tests
- keep a diary of their self-monitoring of blood glucose (SMBG), insulin doses, hypoglycaemic symptoms and blood glucose readings, and the number of times they miss insulin injections.
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 Oct 2020
Shorter than P25 for phase_4
1 active site
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
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedMarch 4, 2025
February 1, 2025
4 months
February 17, 2025
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of TDS PHI compared to BB insulin regimen as assessed by changes in HbA1c measured in percentage
12 weeks
Secondary Outcomes (5)
Changes in FPG measured in mmol/l
12 weeks
Changes in TDD of insulin measured in units
12 weeks
Changes in weight measured in kilograms
12 weeks
Changes in hypoglycemia rate as assessed by episodes per subject year
12 weeks
Adherence to insulin injection as assessed by the frequency of missed doses per month
12 weeks
Study Arms (2)
Group A (Mixtard® 30)
ACTIVE COMPARATORParticipants start on TDS PHI (Mixtard® 30 TDS) and cross over to BB regimen (Insulatard® once daily plus thrice daily prandial Actrapid®) at 12 weeks (visit 4). The initial TDD of insulin equals the baseline TDD of the participants' original insulin regimen and is distributed in a 40:20:40 ratio (breakfast, lunch, and dinner).
Group B (Insulatard® and Actrapid®)
ACTIVE COMPARATORParticipants start on BB regimen (Insulatard® once daily plus thrice daily prandial Actrapid®) and cross over to TDS PHI (Mixtard® 30 TDS) at 12 weeks (visit 4). The initial TDD of insulin equals the baseline TDD of the participants' original insulin regimen and is split between Actrapid® and Insulatard® as 50 and 50 per cent, respectively. Actrapid® is further divided equally across the meals.
Interventions
The clinical use of TDS premixed human insulin (PHI) is unclear. In contrast, biphasic insulin analogue given thrice daily is a well-proven, safe and suitable alternative to an intensified insulin regimen.
Basal bolus regimen is considered a physiological form of treatment and the standard of care in clinical practice but the multiple daily injections often lead to poor compliance.
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes patients
- Age 18 to 65 years
- HbA1c 8 to 12%
- Taking twice-daily (BD) premixed human insulin for at least 6 months
You may not qualify if:
- Age more than 65 years
- Had more than one episode of severe hypoglycaemia within six months
- Received treatment with systemic glucocorticoid therapy or glucose-lowering drugs other than metformin, DPP4 inhibitor and SGLT-2 inhibitor within the last three months
- Cardiac disease with a class III or class IV functional capacity
- Decompensated heart failure, unstable angina or myocardial infarction within the previous six months
- Renal insufficiency with serum creatinine more than 150umol/L
- Active liver disease or deranged liver function tests
- Untreated proliferative retinopathy or maculopathy
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Sultanah Aminah Johor Bahrulead
- Penang Hospital, Malaysiacollaborator
Study Sites (1)
Hospital Pulau Pinang
George Town, Pulau Pinang, 10450, Malaysia
Related Publications (1)
Shanmugasundar G, Bhansali A, Walia R, Dutta P, Upreti V. Comparison of thrice daily biphasic human insulin (30/70) versus basal detemir & bolus aspart in patients with poorly controlled type 2 diabetes mellitus - a pilot study. Indian J Med Res. 2012;135(1):78-83. doi: 10.4103/0971-5916.93428.
PMID: 22382187BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie HI Teoh, MD
Hospital Pulau Pinang, Malaysis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 17, 2025
First Posted
March 4, 2025
Study Start
October 1, 2020
Primary Completion
January 14, 2021
Study Completion
July 1, 2021
Last Updated
March 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share