This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone. Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment. After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm. The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Glucagon-like peptide-1 receptor
sodium-glucose co-transporter 2 (SGLT2) inhibitor
Consano Clinical Research, LLC
Shavano Park, Texas, United States
MAGE
Compare the change in mean amplitude of glucose excursions from baseline to week 14
Time frame: 14 weeks
Fasting Plasma Glucose
Change in fasting plasma glucose from baseline to week 14
Time frame: 14 weeks
HbA1c
Change in HbA1c from baseline to week 14
Time frame: 14 weeks
Weight
Change in weight from baseline to week 14
Time frame: 14 weeks
Blood Pressure
Change in blood pressure from baseline to week 14
Time frame: 14 weeks
Blood Glucose Variability
Variability in blood glucose from baseline to weeks 4, 10 and 14
Time frame: 14 weeks
24 Hour Mean Blood Glucose
Change in 24 mean blood glucose at multiple time points
Time frame: 17 weeks
Blood Glucose Time In Range
Measure the proportion of time patients who had plasma glucose measurements of: \<70 mg/dL, \>70 mg/dL and \<180 mg/dL or \>180 mg/dL
Time frame: 14 weeks
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