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Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital
Plain-language guide to NCT01203774: phase 4 randomized trial of Insulin Glargine, 43 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01203774
- Phase
- phase 4
- Status
- completed
- Start
- 2010-09
- Completion (planned or actual)
- 2013-08
- Participants
- 43 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
The investigators will test this hypothesis in a randomized, crossover trial.
It had two arms (groups): Pen-administered vs syringe-admnistered Glargine (active comparator) and Syringe-administered vs pen-administered Glargine (active comparator).
SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin.
Syringe-administered Glargine insulin and then pen-administered Glargine insulin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 43 actual participants took part.
It was open to people of any sex aged from 22 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, crossover and open-label.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.
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.
It started in 2010-09 with completion listed for 2013-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c at Three Months of Each Period of Treatment (time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)).
It also tracked 1 secondary outcome, for example Compliance and Patient Satisfaction.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 43 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.