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Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
Plain-language guide to NCT00127634: phase 3 randomized trial of Insulin Glargine, 385 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00127634
- Phase
- phase 3
- Status
- completed
- Start
- 2005-07
- Completion (planned or actual)
- 2008-05
- Participants
- 385 (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
This registered phase 3 trial tested Insulin Glargine.
Patients will be treated for 24 months with a 2-month follow-up period.
It had two arms (groups): 1 (experimental) and 2 (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 385 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. Normal lung function.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: severe congestive heart failure; active malignancy; systemic glucocorticoid therapy.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2005-07 with completion listed for 2008-05.
It ran at 61 sites in United States (35), Hungary (8), Belgium (6), Canada (6), India (5) and Croatia (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients (time frame: 24 months).
It also tracked 11 secondary outcomes, for example To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 385 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.