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A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
Plain-language guide to NCT00391027: phase 4 randomized trial of Insulin Glargine, 261 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00391027
- Phase
- phase 4
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2008-08
- Participants
- 261 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Glargine.
It had two arms (groups): Insulin Glargine (Lantus®) (active comparator) and Inhaled Human Insulin (Exubera®) (active comparator).
The registry classes the interventions as drug.
Who Took Part
261 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: Diabetes Mellitus, Type 2 on oral agents. Age \> 30 years.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: severe asthma, severe chronic obstructive pulmonary disease.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2006-12 with completion listed for 2008-08.
It ran at 62 sites in Sweden (16), Germany (8), Spain (8), France (6), Netherlands (5) and Norway (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline, Week 26).
It also tracked 16 secondary outcomes, for example Change From Baseline in HbA1c Prior to Week 26, Change From Baseline in Fasting Plasma Glucose (FPG) Level, Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point), Number of Subjects With Hypoglycemic Events by Severity, Number of Events of Nocturnal Hypoglycemia and Change From Baseline in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 261 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.