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A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
Plain-language guide to NCT04957914: phase 1 non-randomized trial of Insulin Glargine, 54 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04957914
- Phase
- phase 1
- Status
- completed
- Start
- 2021-07-14
- Completion (planned or actual)
- 2022-10-17
- Participants
- 54 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Glargine.
The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM).
Side effects and tolerability will be documented.
The study will last almost six months and 21 visits for each participant including screening period.
It had two arms (groups): Insulin Glargine (Period 1) (active comparator) and LY3209590 (Period 2) (experimental).
Insulin glargine administered subcutaneously (SC).
LY3209590 administered SC.
The registry classes the interventions as drug.
Who Took Part
The registry lists 54 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening. Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²).
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: have an abnormality in the 12-lead ecg; have a supine blood pressure at screening; have alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2.5x upper limit of normal (uln).
How the Study Was Run
The set-up was non-randomized, sequential and open-label.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2021-07-14 with completion listed for 2022-10-17.
It ran at 1 site in Germany.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Incidence of Documented Hypoglycemia (time frame: Baseline through Day 186).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Insulin Glargine in 54 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.