| Outcome Measures: |
Primary: The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups., HbA1c (%, percentage of HbA1c) change from baseline., 48 weeks from baseline | Secondary: Change From Baseline in Fasting Glucose Over Time., 48 weeks from baseline|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%, 24 and 48 weeks|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio), 48 weeks|Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers, 24 and 48 weeks|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication, 24 and 48 weeks|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy, 24 and 48 weeks
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| Locations: |
University of Alabama, Birmingham, Alabama, United States|University of California, San Diego, San Diego, California, United States|Chapel Medical Group, New Haven, Connecticut, United States|Emory University School of Medicine, Atlanta, Georgia, United States|Kaiser Permanente, Tucker, Georgia, United States|Indiana University, Indianapolis, Indiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Medstar Research Institute, Hyattsville, Maryland, United States|Dr. Rudo, Westminster, MD, Westminster, Maryland, 21157, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Michigan, Ann Arbor, Michigan, 48106, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, United States|Columbia University, New York, New York, United States|Lang Medical Center, Queens, New York, United States|Albert Einstein College of Medicine, The Bronx, New York, United States|Carolina's Health Care, Charlotte, North Carolina, United States|University of North Carolina, Durham, North Carolina, United States|University of Texas Southwestern, Dallas, Texas, United States|Scott and White, Temple, Texas, United States
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