Comparison of Insulin Glargine and Regular Insulin Versus NPH and Regular Insulin in the Treatment of T1DM

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

To compare the glycemic control in children with type 1 diabetes using insulin Glargine and regular insulin as basal bolus therapy versus Neutral Protamine Hagedorn insulin (NPH) and regular insulin.

It had two arms (groups): Glargine (experimental) and NPH (active comparator).

Glargine-regular insulin regimen.

NPH- regular insulin regimen.

The registry classes the interventions as drug.

More on the Plan

Diagnosed patients with Type-1 diabetes mellitus (T1DM), who had been on insulin therapy for more than three months, and met the eligibility criteria, were enrolled and randomly divided into group A and group B using the lottery method performed by the nursing staff.

Baseline HbA1c level was done for all the patients using CERA-STAT 2000 analyzer.

The funding from KEMU was used to arrange insulin glargine and glucometer strips.

Patients and their guardians were taught how to use the glucometer and record the measurements on monitoring sheets.

Who Took Part

The registry lists 68 actual participants took part.

It was open to people of any sex aged from 3 years up to 18 years.

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

Examples of who could join: Children of age 3 to 18 years with Type 1 Diabetes Mellitus.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: children below or above 18 years; comorbidities like celiac disease, hypothyroidism.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2019-11-01 with completion listed for 2021-01-05.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: Three months). Hypoglycemia (time frame: Three months). Fasting blood sugar (time frame: Three months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 68 people.

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

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