| Outcome Measures: |
Primary: Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF), Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute., week 0, week 12 | Secondary: Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF), Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute., week 0, week 12|Change in HbA1c (Glycosylated Haemoglobin A1c), Percentage point change in HbA1c, week 0, week 12|Change in Fasting Plasma Glucose (FPG), Change in FPG, week 0, week 12|Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles, The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime., week 0, week 12|Change in Body Weight, week 0, week 12|Fasting Lipid Profile - Change in Total Cholesterol (TC), Change in TC, week 0, week 12|Fasting Lipid Profile - Change in LDL-C, Change in LDL-C, week 0, week 12|Fasting Lipid Profile - Change in HDL-C, Change in HDL-C, week 0, week 12|Fasting Lipid Profile - Change in Triglycerides (TG), Change in TG, week 0, week 12|Biomarkers of Cardiovascular Risk - Change in TNF-alpha, Change in TNF-alpha, week 0, week 12|Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range, Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL)., week 0, week 12|Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range, Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL)., week 0, week 12|Number of Hypoglycaemic Episodes, Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL., weeks 0-12
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