Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

It had two arms (groups): Glargine (experimental) and NPH or premixed 70/30 (human insulin) (active comparator).

Insulin glargine (long-acting insulin analogue).

NPH or premixed 70/30 (human insulin).

The registry classes the interventions as drug.

More on the Plan

Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries.

Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population.

Note: In preparation for results submission, the researchers made minor changes to the outcomes sections to reflect what is listed in the protocol.

For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: the researchers added 12 months measurements (in addition to the 6 months measurement).

Who Took Part

The registry lists 400 actual participants took part.

It was open to people of any sex aged from 7 years up to 25 years.

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

Examples of who could join: Children and young adults (age 7-25). Have a clinical diagnosis of type 1 diabetes (T1D).

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: prior use of any insulin analogue; patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent; who are currently pregnant or plan to become pregnant over the next year.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2023-03-15 with completion listed for 2024-08-13.

It ran at 3 sites in Tanzania (2) and Bangladesh (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time-in-serious Hypoglycemia (time frame: 6 and 12 months after randomization). Time-in-range (TIR) (time frame: 6 and 12 months after randomization).

It also tracked 9 secondary outcomes, for example Time-in-hypoglycemia, Time-above-range, Nocturnal Hypoglycemic Events, Glycemic Control (HbA1c), Rate of Severe Hypoglycemic Events and Rate of Diabetic Ketoacidosis (DKA).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 400 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.