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Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
Plain-language guide to NCT00356109: phase 3 randomized trial of Insulin Glargine, 494 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00356109
- Phase
- phase 3
- Status
- completed
- Start
- 2006-08
- Completion (planned or actual)
- 2008-05
- Participants
- 494 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Glargine.
It had two arms (groups): 1 (experimental) and 2 (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 494 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 1 diabetes for at least 24 months. Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease; systemic glucocorticoid therapy; clinical signs or symptoms of liver disease, acute or chronic hepatitis.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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 2006-08 with completion listed for 2008-05.
It ran at 37 sites in United States (14), Belgium (5), France (5), India (5), Germany (2) and Italy (2).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 4 secondary outcomes, for example Insulin antibody binding levels, To compare HbAlc change and To assess rate and incidence of hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 494 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.