Diabetes Mellitus Type 2 Clinical Trial
Official title:
Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison
to Glimepiride as add on therapy on several parameters characterizing postprandial
metabolism and oxidative stress in type 2 diabetic patients on stable control with
metformin.
This mechanistic phase IV study has a prospective, comparative, open, randomized, two arm
and exploratory design. Overall 40 Patients will be randomized to two treatment arms both
receiving Metformin at a maximally tolerated dose. In addition to that both treatment groups
will receive either an individually titrated dose of Glimepiride or 5mg once daily of
Linagliptin. Subsequent to a standardized meal, several parameters reflecting beta cell
function, metabolism and oxidative stress will be evaluated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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