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ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Plain-language guide to NCT00272064: phase 3 randomized trial of Insulin Glargine, 352 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00272064
- Phase
- phase 3
- Status
- completed
- Start
- 2005-10
- Completion (planned or actual)
- 2008-05
- Participants
- 352 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- 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 (other) and 2 (other).
Telecare system.
Self Monitoring Blood Glucose (SMBG)system.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 352 actual participants took part.
It was open to people of any sex aged from 35 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of type 2 Diabetes Mellitus. Patients having BMI \> 25 Kg/m2;.
The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: patients diagnosed with type 1 insulin dependent diabetes mellitus;; history of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;; impaired renal function.
How the Study Was Run
Design: 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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2005-10 with completion listed for 2008-05.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Changes of glycosilated haemoglobin (HbA1c) (time frame: At least 12 weeks from baseline (visit 3)).
It also tracked 9 secondary outcomes, for example Changes in fasting plasma glucose, Changes in plasma insulin levels, Change of Self-monitoring of Blood Glucose (SMBG), Mean Amplitude Glucose Excursion (MAGE), Change in lipid profile and Body weight - Body Mass Index.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 352 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.