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PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
Plain-language guide to NCT00540709: phase 4 randomized trial of Insulin Glargine, 58 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00540709
- Phase
- phase 4
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2003-09
- Participants
- 58 (actual)
- 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
In this phase 4 trial, researchers set out to test Insulin Glargine.
Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in Type 1 diabetic patients.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 58 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of type 1 diabetes mellitus for at least one year. Subjects with no previous experience with Continuous Subcutaneous Insulin Infusion (CSII) or insulin glargine,. Capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol.
The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: previous therapy using insulin glargine or continuous subcutaneous insulin infusion; unwilling or unlikely to be able to use minimedr insulin pump with insulin lispro for csii; history of more than two severe hypoglycaemic episodes in the past 6 months.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
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 2002-11 with completion listed for 2003-09.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 58 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.