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A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
Plain-language guide to NCT04153981: phase 4 interventional trial of Insulin Glargine, 304 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04153981
- Phase
- phase 4
- Status
- completed
- Start
- 2019-12-16
- Completion (planned or actual)
- 2021-07-30
- Participants
- 304 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
It had 1 arm (groups): Insulin Glargine (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 304 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening. Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days.
The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: have any form of diabetes other than t2dm; have hypersensitivity to the active substance of ly2963016 or to any of the excipients; have a history or diagnosis of human immunodeficiency virus infection, hepatitis b and c.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2019-12-16 with completion listed for 2021-07-30.
It ran at 11 sites in India (11).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number or Participants With Hypoglycemic Events (time frame: Baseline to Week 24).
It also tracked 5 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values and Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 304 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.