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Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Plain-language guide to NCT00911625: phase 4 randomized trial of Insulin Glargine, 114 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00911625
- Phase
- phase 4
- Status
- completed
- Start
- 2009-01-21
- Completion (planned or actual)
- 2011-06-30
- Participants
- 114 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes; Renal Insufficiency
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients.
It had two arms (groups): one (active comparator) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
Participants will be randomized into 1 of 2 protocols after hospital admission.
Blood glucose levels will be obtained before meals, at bedtime and whenever necessary for any signs or symptoms of hypoglycemia.
The 2 study groups will be: 1.
Half of this will be given as glargine once daily.
Who Took Part
114 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 Diabetes Mellitus of mor than 1year. Age greater than 18years.
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: type 1 diabetes mellitus; new onset hyperglycemia; solid organ transplant within 1 year.
How the Study Was Run
Design: 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.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2009-01-21 with completion listed for 2011-06-30.
It ran at 3 sites in United States (3).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Average Blood Glucose Over 6 Days (time frame: 6 Days).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 114 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.