AzTrials
AzTrials

Type 2 Diabetes Mellitus (T2DM)Phase 4NCT06855615

Comparison of Thrice-Daily Premixed Human Insulin With Basal-Bolus Therapy Among Patients With Poorly Controlled Type 2 Diabetes Mellitus

A Phase 4 study testing Mixtard® 30 TDS and Insulatard® once daily and thrice daily prandial Actrapid® in people with Type 2 Diabetes Mellitus (T2DM), run by Hospital Sultanah Aminah Johor Bahru at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Mixtard® 30 TDS and Insulatard® once daily and thrice daily prandial Actrapid®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteMalaysia
Study dates
1 Oct 2020to 1 Jul 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Active liver disease or deranged liver function tests
  • Untreated proliferative retinopathy or maculopathy
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10450

Other trials in Malaysia

About this study

Official title: Comparison of Thrice-Daily Premixed Human Insulin With Basal-Bolus Therapy Among Patients With Poorly Controlled Type 2 Diabetes Mellitus: A Randomised Cross-Over Study

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.
Read more

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.
Read the detailed description

Thrice-daily (TDS) biphasic insulin analogues are suitable alternatives for intensifying insulin therapy, but the clinical use of TDS premixed human insulin (PHI) is unclear. When people with type 2 diabetes mellitus (T2DM) require intensification of treatment, twice daily (BD) PHI is often intensified to a basal-bolus (BB) regimen, but compliance can be poor. The investigators hypothesised that TDS PHI is as efficacious as BB therapy. A cross-over study comparing TDS PHI with BB regimens among people with T2DM is conducted primarily aimed to evaluate and compare the efficacy of TDS PHI (Mixtard® 30) with the BB insulin regimen (Insulatard® once daily plus thrice daily prandial Actrapid®) in T2DM with inadequate glycaemic control on BD PHI and to assess the changes in FPG, TDD of insulin, weight changes, hypoglycaemia rate, and rate of adherence to insulin injection in local setting. Participants receive TDS-PHI or BB for 12 weeks and cross over to the other regimen for another 12 weeks. Glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), the total daily dose (TDD) of insulin, weight, hypoglycaemia, and adherence to insulin injections over 12 weeks are measured.

Being tested
Mixtard® 30 TDS, Insulatard® once daily and thrice daily prandial Actrapid®
Keywords
Type 2 Diabetes Mellitus, thrice-daily premixed human insulin (TDS PHI), basal-bolus regimen, twice-daily premixed human insulin (BD PHI), intensification therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mixtard® 30 TDSDrug

    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.

  • Insulatard® once daily and thrice daily prandial Actrapid®Drug

    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.

Study groups in NCT06855615
Study groupRoleWhat they receive
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).
Receives: Drug: Mixtard® 30 TDS; Drug: Insulatard® once daily and thrice daily prandial Actrapid®
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.
Receives: Drug: Mixtard® 30 TDS; Drug: Insulatard® once daily and thrice daily prandial Actrapid®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of TDS PHI compared to BB insulin regimen as assessed by changes in HbA1c measured in percentage

    Measured: 12 weeks

Secondary outcomes (5)

  1. Changes in FPG measured in mmol/l

    Measured: 12 weeks

  2. Changes in TDD of insulin measured in units

    Measured: 12 weeks

  3. Changes in weight measured in kilograms

    Measured: 12 weeks

  4. Changes in hypoglycemia rate as assessed by episodes per subject year

    Measured: 12 weeks

  5. Adherence to insulin injection as assessed by the frequency of missed doses per month

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start1 Oct 2020
  3. Primary completion14 Jan 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855615
Sponsor's protocol ID
NMRR-20-599-54337
Status last verified
Feb 2025
First submitted
17 Feb 2025
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22382187

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mixtard® 30 TDS and Insulatard® once daily and thrice daily prandial Actrapid® in people with Type 2 Diabetes Mellitus (T2DM), run by Hospital Sultanah Aminah Johor Bahru at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of TDS PHI compared to BB insulin regimen as assessed by changes in HbA1c measured in percentage (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in