Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin

What Was Tested

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

Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals.

It had two arms (groups): Humulin N plus Humulin R (active comparator) and Premix human isophane suspension plus insulin human injection (experimental).

10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals.

10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily.

The registry classes the interventions as drug.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 5 years up to 18 years.

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

Examples of who could join: Male or female 5 - 18 years of age. Be diagnosed for at least 1 year at the date of inclusion. Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits). Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study. Have (patient or guardian) a minimum 4 years primary school level.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: pregnant or lactating females; opposition to participating in the study; residing outside the towns where the care centers are located.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2023-06-15 with completion listed for 2024-04-15.

It ran at 3 sites in Burkina Faso (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example frequency of hypo events (throughout the trial) and correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and NPH Insulin (isophane) in 22 people.

Its size is small, so on its own it can only give an early look.

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 and the NPH Insulin (isophane) compound page, all human trials.