| Outcome Measures: |
Primary: Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus, The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment)., 6 months from baseline | Secondary: Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit, 6 months|A Decrease of ≥0.5% in HbA1c Level at Each Study Visit, 6 months|A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study, 8 months|A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study, 6 months|Body Weight Loss (Compared to Baseline), 6 months
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| Locations: |
Probe Clinical Research Corp., Garden Grove, California, 92843, United States|Pharmax Research Clinic, Miami, Florida, 33126, United States|PMI Health Research Group, Atlanta, Georgia, 30312, United States|Ialim Clinical Research Center, Decatur, Georgia, 30035, United States|Juno Research, LLC, Houston, Texas, 77036, United States|Diabetes Care and Research Centre, Patna, Bihar, 800 020, India|Bharti Research Institute of Diabetes and Endocrinology, Karnal, Haryana, 132 001, India|Bangalore Endocrinology and Diabetes Research Centre, Bangalore, Karnataka, 560 003, India|Medisys Clinisearch India Pvt. Ltd., Bangalore, Karnataka, 560 043, India|Belgaum Diabetes Centre, Belgaum, Karnataka, 590 001, India|Krishna Diabetes Clinic and Educational Research Centre, Bhopal, Madhya Pradesh, 462 003, India|Diabetes Thyroid Hormone Research Institute Pvt. Ltd, Indore, Madhya Pradesh, 452 001, India|Research Health Institute in Diabetes Endocrinology and Metabolism, Mumbai, Maharashtra, 400 014, India
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