| Outcome Measures: |
Primary: Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo, From baseline to Week 4 | Secondary: Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System, Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16. Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then., From baseline to Week 16|Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System, Area under curve for glucose levels \>180 mg/dL over 72 hours, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System, From baseline to Week 16|Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo, From baseline to Week 16|Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes, Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes, Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes, Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes, Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16, From baseline to Week 16|Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group, Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment, From baseline to 30 days post-treatment|Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes in systolic blood pressures from baseline to Week 16, From baseline to Week 16|Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, From baseline to Week 16|Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, From baseline to Week 16|Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes in total cholesterol from baseline to Week 16., From baseline to Week 16|Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo, From baseline to Week 16|Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo, From baseline to Week 16|Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain., From baseline to Week 16|Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes to question of "how full do you feel" in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full., From baseline to Week 16|Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes in daily calories intake from baseline to Week 16, From baseline to Week 16|Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis, From baseline to Week 16 | Other: Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, From baseline to Week 16|Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, From baseline to Week 4, Week 8, Week 12, and Week 16|Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo, From baseline to Week 4, Week 8, Week 12, and Week 16
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