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Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
Plain-language guide to NCT00469586: phase 3 randomized trial of Insulin (regular human), 174 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00469586
- Phase
- phase 3
- Status
- terminated early
- Start
- 2007-04-26
- Completion (planned or actual)
- 2008-04-24
- Participants
- 174 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; 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 (regular human).
This trial is conducted in Europe, Asia, North America and South America.
It had three arms (groups): A (experimental), B (experimental) and C (active comparator).
The registry classes the interventions as drug.
More on the Plan
The decision to discontinue the development of AERx® is not due to any safety concerns.
Who Took Part
174 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 2 diabetes. Treated with OADs for more than or equal to 3 months. Body Mass Index (BMI) less than or equal to 40.0 kg/m2.
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: recurrent major hypoglycaemia; current smoking or smoking within the last 6 months; impaired hepatic or renal function.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin (regular human) study did not mask who received what.
It started in 2007-04-26 with completion listed for 2008-04-24.
It ran at 59 sites in Canada (11), Poland (8), Belgium (6), France (6), Austria (5) and India (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c change from baseline (time frame: After 18 weeks of treatment).
It also tracked 5 secondary outcomes, for example Adverse events, Body weight, Lung function, Blood glucose and Hypoglycaemia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 174 people.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.