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

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

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).

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.

It had two arms (groups): Group A (Mixtard® 30) (active comparator) and Group B (Insulatard® and Actrapid®) (active comparator).

Participants 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).

Participants 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.

The registry classes the interventions as drug.

More on the Plan

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.

Participants receive TDS-PHI or BB for 12 weeks and cross over to the other regimen for another 12 weeks.

Who Took Part

44 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 Diabetes patients. Age 18 to 65 years. Taking twice-daily (BD) premixed human insulin for at least 6 months.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2020-10-01 with completion listed for 2021-01-14.

It ran at 1 site in Malaysia.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Changes in FPG measured in mmol/l, Changes in TDD of insulin measured in units, Changes in weight measured in kilograms and Changes in hypoglycemia rate as assessed by episodes per subject year.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.