drugset / Trial / NCT00313937

SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

NCT00313937 ↗

Phase 4 Completed 91 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2001-11
Primary completion
2004-06
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — —