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Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
Plain-language guide to NCT02227212: phase 3 interventional trial of Insulin Glargine, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02227212
- Phase
- phase 3
- Status
- completed
- Start
- 2014-08
- Completion (planned or actual)
- 2014-11
- Participants
- 40 (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
In this phase 3 trial, researchers set out to test Insulin Glargine.
The safety and usability of the U300 pen injector.
It had 1 arm (groups): Insulin glargine U300 (experimental).
Once daily subcutaneous injection for 4 weeks.
The registry classes the interventions as drug.
More on the Plan
The total study duration for a participants can be approximately up to 10 weeks.
Who Took Part
40 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: Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate. Signed written informed consent.
The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: age \<18 years at the time of screening; body mass index (bmi) \>40 kg/m2; diabetes other than t2dm.
How the Study Was Run
Design: 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 2014-08 with completion listed for 2014-11.
It ran at 7 sites in Germany (7).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Ease-of-use / ease of learning questionnaire (time frame: Day 1, Day 7 , 4-weeks).
It also tracked 10 secondary outcomes, for example Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4, Number of participants with Product Technical Complaints (PTC), Number of participants with adverse events and hypoglycemic events related to PTC, Number of participants with adverse events and Number of participants with site injection site reactions / hypersensitivity reactions.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Insulin Glargine in 40 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.