| Outcome Measures: |
Primary: Change from Baseline in Matrix Metallo Proteinase 9., The change between Matrix Metallo Proteinase 9 collected at final visit or week 24 and Matrix Metallo Proteinase 9 collected at baseline., Baseline and Week 24. | Secondary: Change from Baseline in 24-hour Blood Pressure Profile., The change between the 24-hour Blood Pressure Profile recorded at final visit or week 24 and 24-hour Blood Pressure Profile recorded at baseline., Baseline and Week 24.|Change from Baseline in Intima Media Thickness., The change between the value of Intima Media Thickness measured at final visit or week 24 and Intima Media Thickness measured at baseline., Baseline and Week 24.|Change from Baseline in 24-hour Urinary Sample., The change between the value of urine participants collect 24 hours before final visit or week 24 and urine participants collect 24 hours before baseline., Baseline and Week 24.|Change from Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide., The change between the value of N-terminal Pro-hormone Brain Natriuretic Peptide collected at final visit or week 24 and N-terminal Pro-hormone Brain Natriuretic Peptide collected at baseline., Baseline and Week 24.|Change from Baseline in 8-iso Prostaglandin F2 alpha., The change between the value of 8-iso Prostaglandin F2 alpha collected at final visit or week 24 and 8-iso Prostaglandin F2 alpha collected at baseline., Baseline and Week 24.|Change from Baseline in Albumin., The change between the value of Albumin collected at final visit or week 24 and Albumin collected at baseline., Baseline and Week 24.|Change from Baseline in Creatinine., The change between the value of Creatinine collected at final visit or week 24 and Creatinine collected at baseline., Baseline and Week 24.|Change from Baseline in C/A-quotient., The change between the value of C/A-quotient collected at final visit or week 24 and C/A-quotient collected at baseline., Baseline and Week 24.|Change from Baseline in Homeostasis Model Assessment - Insulin Sensitivity., The change between Homeostasis Model Assessment of Insulin Sensitivity collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Sensitivity collected at baseline. Homeostatis Model Assessment measures insulin sensitivity, calculated by fasting insulin times fasting glucose, divided by a constant (22.5)., Baseline and Week 24.|Change from Baseline in Total Cholesterol., The change between the value of Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline., Baseline and Week 24.|Change from Baseline in Low-Density Lipoprotein., The change between the value of Low-Density Lipoprotein collected at final visit or week 24 and Low-Density Lipoprotein collected at baseline., Baseline and Week 24.|Change from Baseline in High-Density Lipoprotein., The change between the value of High-Density Lipoprotein collected at final visit or week 24 and High-Density Lipoprotein collected at baseline., Baseline and Week 24.|Change from Baseline in Triglycerides., The change between the value of Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline., Baseline and Week 24.|Change from Baseline in Glycosylated Hemoglobin., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 24.|Change from Baseline in Glucose., The change between the value of Glucose collected at final visit or week 24 and Glucose collected at baseline., Baseline and Week 24.|Change from Baseline in Insulin., The change between the value of Insulin collected at final visit or week 24 and Insulin collected at baseline., Baseline and Week 24.|Change from Baseline in Intact Proinsulin., The change between the value of Intact Proinsulin collected at final visit or week 24 and Intact Proinsulin collected at baseline., Baseline and Week 24.|Change from Baseline in C-peptide., The change between the value of C-peptide collected at final visit or week 24 and C-peptide collected at baseline., Baseline and Week 24.|Change from Baseline in Adiponectin., The change between the value of Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline., Baseline and Week 24.|Change from Baseline in High Molecular Weight Adiponectin., The change between the value of High Molecular Weight Adiponectin collected at final visit or week 24 and High Molecular Weight Adiponectin collected at baseline., Baseline and Week 24.|Change from Baseline in High-Sensitivity C-Reactive Protein., The change between the value of High-Sensitivity C-Reactive Protein collected at final visit or week 24 and High-Sensitivity C-Reactive Protein collected at baseline., Baseline and Week 24.|Change from Baseline in Fibrinogen., The change between the value of Fibrinogen collected at final visit or week 24 and Fibrinogen collected at baseline., Baseline and Week 24.|Change from Baseline in E-selectin, The change between the value of E-selectin collected at final visit or week 24 and E-selectin collected at baseline., Baseline and Week 24.|Change from Baseline in Nuclear Factor-kappa B., The change between the value of Nuclear Factor-kappa B collected at final visit or week 24 and Nuclear Factor-kappa B collected at baseline., Baseline and Week 24.|Change from Baseline in Plasminogen Activator Inhibitor-1., The change between the value of Plasminogen Activator Inhibitor-1 collected at final visit or week 24 and Plasminogen Activator Inhibitor-1 collected at baseline., Baseline and Week 24.|Change from Baseline in Nitrotyrosine., The change between the value of Nitrotyrosine collected at final visit or week 24 and Nitrotyrosine collected at baseline., Baseline and Week 24.|Change from baseline in Insulin Consumption., The change between the value of Insulin collected at final visit or week 24 and Insulin collected at baseline., Baseline and Week 24.|Change from Baseline in Endothelial Function measured by Laser-Doppler-flowmetry., The change between the value of Endothelial Function measured at final visit or week 24 and Endothelial Function measured at baseline., Baseline and Week 24.|Change from Baseline in Body Weight., The change between the value of the participant's Body Weight recorded at final visit or week 24 and the participant's Body Weight recorded at baseline., Baseline and Week 24.|Change from Baseline in Electrocardiograms, The change between the value of Electrocardiograms measured at final visit or week 24 and Electrocardiograms measured at baseline., Baseline and Week 24.|Change from Baseline in Alanine Aminotransferase Laboratory Safety Variable., The change between the value of Alanine Aminotransferase collected at final visit or week 24 and Alanine Aminotransferase collected at baseline., Baseline and Week 24.|Change from Baseline in Aspartate Aminotransferase Laboratory Safety Variable., The change between the value of Aspartate Aminotransferase collected at final visit or week 24 and Aspartate Aminotransferase collected at baseline., Baseline and Week 24.|Change from Baseline in Gamma-glutamyl transferase Laboratory Safety Variable., The change between the value of Gamma-glutamyl transferase collected at final visit or week 24 and Gamma-glutamyl transferase collected at baseline., Baseline and Week 24.|Change from Baseline in Glomerular Filtration Rate Laboratory Safety Variable., The change between the value of Glomerular Filtration Rate collected at final visit or week 24 and Glomerular Filtration Rate collected at baseline., Baseline and Week 24.|Change from Baseline in Alkaline Phosphatase Laboratory Safety Variable., The change between the value of Alkaline Phosphatase collected at final visit or week 24 and Alkaline Phosphatase collected at baseline., Baseline and Week 24.|Change from Baseline in Leucocytes Laboratory Safety Variable., The change between the value of Leucocytes collected at final visit or week 24 and Leucocytes collected at baseline., Baseline and Week 24.|Change from Baseline in Hemoglobin Laboratory Safety Variable., The change between the value of Hemoglobin collected at final visit or week 24 and Hemoglobin collected at baseline., Baseline and Week 24.|Change from Baseline in Thrombocytes Laboratory Safety Variable., The change between the value of Thrombocytes collected at final visit or week 24 and Thrombocytes collected at baseline., Baseline and Week 24.|Change from Baseline in Creatinine Kinase Laboratory Safety Variable., The change between the value of Creatinine Kinase collected at final visit or week 24 and Creatinine Kinase collected at baseline., Baseline and Week 24.|Change from Baseline in Creatinine Laboratory Safety Variable., The change between the value of Creatinine collected at final visit or week 24 and Creatinine collected at baseline., Baseline and Week 24.|Change from Baseline in Capillary Blood Glucose Laboratory Safety Variable., The change between the value of Capillary Blood Glucose collected at final visit or week 24 and Capillary Blood Glucose collected at baseline., Baseline and Week 24.|Change from Baseline in Potassium Laboratory Safety Variable., The change between the value of Potassium collected at final visit or week 24 and Potassium collected at baseline., Baseline and Week 24.|Change from Baseline in Circadian (7 point) Blood Glucose Profile (Week 24)., The change between Circadian Blood Glucose measured before week 24 or final visit and Circadian Blood Glucose measured before baseline. Participants measure their blood glucose levels 7 times (before and after breakfast, before and after lunch, before and after dinner and before going to bed) on two arbitrary days and record these measurements in their diaries., Baseline and Week 24.|Change from Baseline in Circadian (7 point) Blood Glucose Profile (Week 12)., The change between Circadian Blood Glucose measured before week 12 and Circadian Blood Glucose measured before baseline. Participants measure their blood glucose levels 7 times (before and after breakfast, before and after lunch, before and after dinner and before going to bed) on two arbitrary days and record these measurements in their diaries., Baseline and Week 12.
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| Locations: |
Lichtenfels, Bavaria, Germany|Frankfurt, Hessen, Germany|Kassel, Hessen, Germany|Wiesbaden, Hessen, Germany|Bad Oeynhausen, North Rhine-Westphalia, Germany|Dinslaken, North Rhine-Westphalia, Germany|Duisburg, North Rhine-Westphalia, Germany|Essen, North Rhine-Westphalia, Germany|Münster, North Rhine-Westphalia, Germany|Wuppertal, North Rhine-Westphalia, Germany|Mainz, Rheinland-Pfalz, Germany|Diez, Rhineland-Palatinate, Germany|Landau, Rhineland-Palatinate, Germany|Dresden, Saxony, Germany|Leipzig, Saxony, Germany|Jena, Thüringen, Germany|Berlin, Germany|Hamburg, Germany
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