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Plain-language guide to NCT01013571: phase 4 randomized trial of Insulin Glargine, 493 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01013571
- Phase
- phase 4
- Status
- completed
- Start
- 2009-10
- Completion (planned or actual)
- 2012-01
- Participants
- 493 (actual)
- Design
- randomized, 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
This registered phase 4 trial tested Insulin Glargine.
It had two arms (groups): 1 (experimental) and 2 (experimental).
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed.
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 493 actual participants took part.
It was open to people of any sex aged from 30 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Completed run-in phase.
The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: no food intake before lunch (noon); nightshift worker; type 1 diabetes mellitus.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
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 2009-10 with completion listed for 2012-01.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Change in HbA1c, FG, and 7-point glucose profile, Change in weight, Incidence of hypoglycemia, Treatment satisfaction (DTSQ for patient ) and Adherence with the patient-managed monitoring algorithm.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 493 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.