| Outcome Measures: |
Primary: Time in range at week 13, Time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hours over the 7-day CGM period at week 13 after randomization, 7 days|Time in range within 12-hours (6 AM -6 PM) at week 13, Time with CGM glucose between 4.0 - 10.0 mmol/L within 12-hours (6 AM -6 PM) over the 7-day CGM period at week 13 after randomization, 7 days | Secondary: Daily glucose standard deviation (SD) at week 13, Daily SD of CGM glucose over the 7-day CGM period at week 13 after randomization, 7 days|Overall SD of CGM glucose at week 13, Overall SD of CGM glucose over the 7-day CGM period at week 13 after randomization, 7 days|Mean of glucose at week 13, Mean of CGM glucose over the 7-day CGM period at week 13 after randomization, 7 days|Frequency of hypoglycemia at week 13, Number of hypoglycemic event which is defined as CGM glucose \<4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization, 7 days|Time in hypoglycemia at week 13, Time with CGM glucose \< 4.0 mmol/L over the 7-day CGM period at week 13 after randomization, 7 days|Frequency of hyperglycemia at week 13, Number of hyperglycemic event which is defined as CGM glucose \>10.0 mmol/L at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization, 7 days|Time in hyperglycemia at week 13, Time with CGM glucose \>10.0 mmol/L over the 7-day CGM period at week 13 after randomization, 7 days|Daily glucose standard deviation (SD) within 12 hours (6AM-6PM) at week 13, Daily SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Overall SD of glucose within 12 hours (6AM-6PM) at week 13, Overall SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Mean of glucose within 12 hours (6AM-6PM) at week 13, Mean of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Frequency of hypoglycemia within 12 hours (6AM-6PM) at week 13, Number of hypoglycemic event which is defined as CGM glucose \<4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Time in hypoglycemia within 12 hours (6AM-6PM) at week 13, Time with CGM glucose \<4.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Frequency of hyperglycemia within 12 hours (6AM-6PM) at week 13, Number of hypoglycemic event which is defined as CGM glucose \>10.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|Time in hyperglycemia within 12 hours (6AM-6PM) at week 13, Time with CGM glucose \>10.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization, 7 days|A1C mean at week 13, Average of A1C at week 13 after randomization, Week 13|Changes A1C, A1C value at Visit10 at 13 weeks after randomization minus A1C value at Visit 1 at week -2 (2 weeks before randomization), 15 weeks|Proportion of A1C <7% at week 13, the number of patients who have A1C \<7% divided by the total number of patients who have A1C measurement at week 13 after randomization, Week 13|Proportion of A1C <8% at week 13, the number of patients who have A1C \<8% divided by the total number of patients who have A1C measurement at week 13 after randomization, Week 13|Mean basal insulin dose at week 13, Average of basal insulin dose from patients' diary at week 13 after randomization, Week 13|Change in weight, Weight difference between week 13 after randomization and baseline at week -2 (2 weeks before randomization) = weight at Visit 10 at week 13 - weight at Visit 1 at week -2., 15 weeks|Change in waist circumference, Waist circumference change between week 13 after randomization and baseline at week -2 (2 week before randomization)= waist circumference at Visit 10 at week 13- waist circumference at Visit 1 at week -2, 15 weeks|Change in carbohydrate intake, Carbohydrate intake change between week 13 after randomization and baseline at week -1 = carbohydrate intake at Visit 10 at week 13 - carbohydrate intake at Visit 2 at week -1 (1 week before randomization), 14 weeks|Proportion of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline, the number of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline divided by the total number of patients at Week 13 after randomization, Week 13|Proportion of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline, the number of patients who have A1C ≤ 7% with no hypoglycemia and weight gain \<3% from baseline divided by the total number of patients at Week 13 after randomization, Week 13|Proportion of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia, the number of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia divided by the total number of patients at Week 13 after randomization, Week 13|Change in DiabMedSat Score, DiabMedSat Score will be generated using Diabetes Medication Satisfaction (DiabMedSat) questionnaire. It measures the levels of the subjects' satisfaction with their diabetes medication(s). The range of the score is 0 to 100. The higher the score, the greater the satisfaction. The changes in the score will measure the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization), 14 weeks|Change in HFS Score, HFS Score will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear. The changes will be the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization)., 14 weeks|HCP treatment satisfaction score, HCP treatment satisfaction score will be generated from Healthcare Provider treatment satisfaction questionnaire. It measures the levels of satisfaction of physicians in this study when prescribing this medication at Visit 10 at week 13 after randomization. The range is 0 to 15. The higher the score, the greater the satisfaction., Week 13
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| Locations: |
LMC Brampton, Brampton, Ontario, L6S 0C9, Canada|LMC Etobicoke, Etobicoke, Ontario, Canada|LMC Scarborough, Toronto, Ontario, M1R 0B1, Canada
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