The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus

What Was Tested

The trial (phase 2) is built around Insulin Glargine.

It had two arms (groups): Insulin Glargine Sansulin (experimental) and Insulin Glargine Lantus (active comparator).

The registry classes the interventions as drug.

More on the Plan

Sansulin® Log-G is an insulin glargine biosimilar.

Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors.

Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening.

Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with DM type 2, age at least 18 years, both genders. Patients who are cooperative, reliable, and agree to have regular injections of insulin, and are willing to comply with protocol procedure (willing to sign the informed consent).

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: pregnancy (confirmed by a positive urine pregnancy test) or lactation; history of diabetic ketoacidosis \> 2x within the last year; having hyperglycemia hyperosmolar status (hhs).

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

In this single-blind Insulin Glargine study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2020-10 with completion listed for 2021-08.

It ran at 1 site in Indonesia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: 24 weeks). Number of patients (time frame: 24 weeks). Anti-insulin antibodies (AIAs) (time frame: 24 weeks).

It also tracked 4 secondary outcomes, for example FBG & PPBG, Hypoglycemia, Weight gain and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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