drugset / Trial / NCT00151697

LANN-study: Lantus, Amaryl, Novorapid, Novomix Study

NCT00151697

Phase 3 Completed 150 enrolled Rijnstate Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.

Timeline

Start
2005-05
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule
Subject biphasic insulin aspart Protein / enzyme biologic
Subject insulin aspart Protein / enzyme biologic
Subject insulin glargine Protein / enzyme biologic