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A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
Plain-language guide to NCT00134147: phase 3 randomized trial of Insulin (regular human), 1100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00134147
- Phase
- phase 3
- Status
- completed
- Start
- 2005-04
- Completion (planned or actual)
- 2007-05
- Participants
- 1100
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin (regular human).
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents.
The registry classes the interventions as drug.
Who Took Part
1100 planned participants were the target.
It was open to people of any sex aged from 35 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diabetes mellitus Type 2. Failing two or more oral anti-diabetic agents.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: asthma, copd.
How the Study Was Run
The set-up was 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 2005-04 with completion listed for 2007-05.
It ran at 121 sites in Germany (35), United Kingdom (21), United States (18), Italy (14), Spain (14) and Canada (10).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Glycosylated hemoglobin.
It also tracked 5 secondary outcomes, for example Percent of patients achieving good control of fasting glucose and lipids, Rate of hypoglycemia, Changes in body weight, Patient satisfaction and Safety based on adverse events reported and laboratory tests.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 1100 people.
With 1100 participants it is a large trial for this field.
The trial is marked completed; 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.