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Insulin Glulisine in Type 2 Diabetic Patients
Plain-language guide to NCT00360698: phase 4 randomized trial of Insulin Glargine, 106 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00360698
- Phase
- phase 4
- Status
- completed
- Start
- 2006-07
- Completion (planned or actual)
- 2008-08
- Participants
- 106 (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
This registered phase 4 trial tested Insulin Glargine.
It had two arms (groups): insulin glulisine+insulin glargine+metformin+glimepiride (other) and insulin glargine+metformin+glimepiride (other).
Bolus arm.
Control arm.
The registry classes the interventions as drug.
Who Took Part
The registry lists 106 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diabetes Mellitus, Type 2. 25 \< BMI \< 45 kg/m².
The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: type 1 diabetes mellitus; treatment with oads only; treatment with thiazolidinediones, with exenatide or with pramlintide.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
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 2006-07 with completion listed for 2008-08.
It ran at 3 sites in United States (1), Russia (1) and United Kingdom (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 10 secondary outcomes, for example Glycosylated Haemoglobin (HbA1c) Value, Change in Glycosylated Haemoglobin (HbA1c) Value, Daily Mean Plasma Glucose, Change in Daily Mean Plasma Glucose, Change in Weight and Rate of Severe Symptomatic Hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 106 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.