← Human Trials & Peer-Reviewed Studies
Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
Plain-language guide to NCT02967237: phase 4 interventional trial of Insulin Glargine, 136 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02967237
- Phase
- phase 4
- Status
- completed
- Start
- 2016-01-04
- Completion (planned or actual)
- 2017-07-24
- Participants
- 136 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
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 (U300) (experimental).
Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen.
The registry classes the interventions as drug.
More on the Plan
The total study duration per patient is approximately 28 weeks.
Who Took Part
Enrollment: 136 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: Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: use of prandial insulin; use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-01-04 with completion listed for 2017-07-24.
It ran at 85 sites in France (85).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Mean change from baseline in HbA1c (time frame: Baseline, Week 24).
It also tracked 8 secondary outcomes, for example Mean change from baseline in fasting plasma glucose, Change in Diabetes Treatment Satisfaction Questionnaire score, Number of hypoglycemic events and Number of adverse events.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 136 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.