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Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
Plain-language guide to NCT03352674: phase 2 randomized trial of Insulin Glargine, 133 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03352674
- Phase
- phase 2
- Status
- completed
- Start
- 2016-09
- Completion (planned or actual)
- 2018-12-01
- Participants
- 133 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Insulin Glargine.
It had two arms (groups): Insulin Glargine Ezelin (experimental) and Insulin Glargine Lantus (active comparator).
Insulin Glargine Pen Injector \[Lantus\].
The registry classes the interventions as drug.
Who Took Part
133 actual participants took part.
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: Men or women, 18 years old and above. BMI ranged from 19 - 35 kg/m2. Consent from patients of childbearing potential to use contraception method throughout the study. Signed informed consent form.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: history of diabetic ketoacidosis more than 2 times in the past 1 year; history of pancreatectomy; positive znt8 antibody.
How the Study Was Run
The set-up was 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.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
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 2016-09 with completion listed for 2018-12-01.
It ran at 1 site in Indonesia.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Incidence of immune response (time frame: 6 months).
It also tracked 4 secondary outcomes, for example HbA1c, Fasting blood glucose, Hypoglycemia and Adverse events.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Insulin Glargine in 133 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.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.