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SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
Plain-language guide to NCT00313937: phase 4 randomized trial of Insulin Glargine, 91 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00313937
- Phase
- phase 4
- Status
- completed
- Start
- 2001-11
- Completion (planned or actual)
- 2004-06
- Participants
- 91 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- 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.
Primary objective: To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.
Secondary objective: To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).
The registry classes the interventions as drug.
Who Took Part
91 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.
The full record lists 0 inclusion and 6 exclusion criteria; among the exclusions: history of hypersensitivity to the study medication or to drugs with similar chemical structures; likelihood of requiring treatment during the study period with drugs not permitted by the study protocol; treatment with any investigational drug in the last 30 days before study entry.
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.
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 2001-11 with completion listed for 2004-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Difference of change of blood glucose between patients on Insulin glargine and NPH insulin (time frame: between 7:00 am and 11:00 am).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 91 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.