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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy
Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy
ikfe GmbH
Mainz, Rhineland-Palatinate, Germany
RECRUITINGPostprandial increase in intact Proinsulin levels (Peak, AUC)
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Postprandial Proinsulin/Insulin Ratio
Time frame: after 12 weeks treatment
Fasting intact Proinsulin levels
Time frame: after 12 weeks treatment
Fasting Proinsulin/Insulin Ratio
Time frame: after 12 weeks treatment
Fasting Blood Glucose
Time frame: after 12 weeks treatment
Postprandial Blood Glucose Excursions (Peak; AUC)
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Fasting Lipids
Time frame: after 12 weeks treatment
Postprandial Lipids
Time frame: after 12 weeks treatment
Fasting Erythrocyte Flexibility
Time frame: after 12 weeks treatment
Postprandial Erythrocyte Flexibility
Time frame: after 12 weeks treatment
Fasting GLP-1 levels
Time frame: after 12 weeks treatment
Postprandial GLP-1 levels
Time frame: after 12 weeks treatment
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Fasting cGMP
Time frame: after 12 weeks treatment
Postprandial cGMP
Time frame: after 12 weeks treatment
Fasting Calcitonin
Time frame: after 12 weeks treatment
Fasting PAI-1 levels
Time frame: after 12 weeks treatment
Postprandial PAI-1 levels
Time frame: after 12 weeks treatment
Fasting ADMA levels
Time frame: after 12 weeks treatment
Postprandial ADMA levels
Time frame: after 12 weeks treatment
Fasting Malonyldialdehyd
Time frame: after 12 weeks treatment
fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo
Time frame: after 12 weeks treatment
Hypoglycemic events
Time frame: after 12 weeks treatment
Body Weight
Time frame: after 12 weeks treatment