PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): Sequence 1 (experimental) and Sequence 2 (active comparator).

Gan \& Lee insulin glargine followed by Lantus.

Lantus followed by Gan \& Lee insulin glargine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 41 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: Female and Male subjects with T1DM, duration ≥12 months. Adults ≥ 18 to ≤ 65 years of age. Body mass index (BMI) ≥ 18.5 to ≤ 30.0 kg/m2. Weight ≥ 50 kg. Current stable treatment with insulin (consistent therapy with multiple daily injections with basal and bolus insulin or CSII).

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

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

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-12 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 5 secondary outcomes, for example Safety assessment as measured by incidence and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 41 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.