Time in Glucose Range [ Time Frame: Week 22 to Week 26 ]
Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26
Nocturnal Hypoglycemia Event Rate [ Time Frame: Baseline to Week 52 ]
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.
Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 26 ]
Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).
Glucose Variability [ Time Frame: Week 22 to Week 26 ]
Glucose variability measured by CGM 4 weeks prior to week 26
Basal Insulin Dose [ Time Frame: Week 26 ]
Bolus Insulin Dose [ Time Frame: Week 26 ]
Total Insulin Dose [ Time Frame: Week 26 ]
Rate of Composite Level 2 and 3 Hypoglycemia Events [ Time Frame: Baseline to Week 52 ]
Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
Time in Hypoglycemia Range [ Time Frame: Week 22 to Week 26 ]
Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26.
Time in Hyperglycemia Range [ Time Frame: Week 22 to Week 26 ]
Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [ Time Frame: Baseline, Week 26 ]
DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 26 ]
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Source: View full study details on ClinicalTrials.gov
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