| Outcome Measures: |
Primary: 2 hr PPG, Change from baseline to week 12 in area under the curve (AUC) 2-hr post-prandial glucose (PPG) excursions in subjects receiving BTI320 compared with those subjects receiving placebo., Week 12 | Secondary: HbA1c, Change in Hemoglobin A1c (HbA1c) serum levels from baseline, Weeks 3, 6, and 12|2 hr PPG, Change from baseline of AUC 2-hr PPG, Weeks 3 and 6|1 hr PPG, Change from baseline of AUC 1-hr PPG, Weeks 3, 6, and 12|3 hr PPG, Change from baseline of AUC 3-hr PPG, Weeks 3, 6, and 12|BMI, Change in Body Mass Index (BMI) from baseline, Week 12|Lipids, Change in serum lipid levels from baseline, Weeks 3, 6, and 12|Blood Pressure, Change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP) from baseline, Week 12|hsCRP concentration, Change in serum highly sensitive C-reactive protein (hsCRP) levels from baseline, Weeks 3, 6, and 12|C-peptide/insulin concentration, Change in serum C-peptide or insulin levels from baseline, Weeks 3, 6, and 12|Fasting blood glucose concentration, Change in fasting blood glucose from baseline, Weeks 3, 6, and 12|CGMS, Change in the AUC in Continuous Glucose Monitoring System (CGMS) from baseline, Three days starting at Baseline, Weeks 3, 6, and 11|Change in oral hypoglycemic medication, Change in oral hypoglycemic medication dosage, Weeks 3, 6, and 12
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| Locations: |
Coastal Metabolic Research Center, Inc., Ventura, California, 93003, United States|Albuquerque Clinical Trials, Albuquerque, New Mexico, 87102, United States|Coastal Carolina Research Center, Mount Pleasant, South Carolina, 29464, United States|Advanced Research Institute, Ogden, Utah, 84405, United States
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