To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.
This will be a 52 week study for type 1 diabetics looking into the effect of semaglutide and dapagliflozin on HbA1c and glycemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
Standard of care insulin for pump or injection and serves as a control
Injectable weekly GLP-1RA given as open label experimental drug
Oral daily SGLT2 Inhibitor given as experimental drug
Diabetes and Endocrinology Research Center of WNY
Williamsville, New York, United States
Change in HbA1c following dapagliflozin
Change in HbA1c at 6 months following dapagliflozin or placebo therapy in addition to combined semaglutide and insulin treatment.
Time frame: 6 months
Change in HbA1c with triple therapy
Change in HbA1c from baseline at 12 months in triple therapy group compared to insulin only group.
Time frame: 12 months
Change in HbA1c with semaglutide
Change in HbA1c from baseline at 6 months in dual therapy group (insulin and semaglutide) compared to insulin only group.
Time frame: 6 months
Assessment of hyperglycemia level 1
Change in percent Time hyperglycemia Level 1(180-250mg/dl) as assessed by CGM
Time frame: 12 months
Assessment of hyperglycemia level 2
Change in percent Time in hyperglycemia Level 2 ( \>250mg/dl) as assessed by CGM
Time frame: 12 months
Assessment of hypoglycemia
Change in percent Time in hypoglycemia Level 1 (54-70mg/dl) as assessed by CGM
Time frame: 12 months
Assessment of percent time glucose in range
Change in percent Time in Range (70- 180 mg/dl) as assessed by CGM
Time frame: 12 months
Fructosamine indices
Assessment of fructosamine
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Placebo to Dapagliflozin given as a control to the experimental drug
Time frame: 12 months
Weekly fasting glucose indices
Assessment of change of weekly fasting glucose
Time frame: 12 months
Insulin requirement indices
Assessment of the change in insulin requirement
Time frame: 12 months
body weight assessment following dapagliflozin
Change in body weight at 6 months between dapagliflozin and placebo groups.
Time frame: 6 months
body weight assessment following semaglutide
Change in body weight at 6 months following starting semaglutide compared to standard of care (SOC) group.
Time frame: 6 months
body weight assessment following triple therapy
Change in body weight as assessed at 12 months on dapagliflozin and semaglutide compared to SOC therapy.
Time frame: 12 months
Systolic Blood pressure assessment after triple therapy
Anti-hypertensive effects including change in systolic BP on dapagliflozin and semaglutide compared to SOC therapy.
Time frame: 12 months
Diastolic Blood pressure assessment
Anti-hypertensive effects including change in diastolic BP on dapagliflozin and semaglutide compared to SOC therapy.
Time frame: 12 months
Blood pressure medication use
Anti-hypertensive effects including change in numbers of BP medications required in patients dapagliflozin and semaglutide compared to SOC therapy.
Time frame: 12 months
Level 2 hypoglycemia assessment
Differences in rates of hypoglycemic events Level 2 (\<54mg/dl) between triple therapy and in standard therapy arm.
Time frame: 12 months
Severe (level 3) hypoglycemia assessment
Differences in rates of hypoglycemic events Level 3 (\<54mg/dl) characterized by altered mental and/or physical status requiring assistance) between triple therapy and in standard therapy arm.
Time frame: 12 months
Level 1 hyperglycemia assessment
Differences in rates of Level 1 hyperglycemia (glucose levels \>180mg/dl and \<250mg dl) between triple therapy and in standard therapy arm.
Time frame: 12 months
Level 2 hyperglycemia assessment
Differences in rates of Level 2 hyperglycemia (glucose levels \<250mg dl) between triple therapy and in standard therapy arm.
Time frame: 12 months
serum ketones assessment
Differences in rates of diabetic ketoacidosis defined as elevated serum ketones (greater than the upper limit of the normal range) in investigative arms.
Time frame: 12 months
Urinary ketones assessment
Differences in rates of diabetic ketoacidosis defined as elevated urine ketones (greater than the upper limit of the normal range) in investigative arms.
Time frame: 12 months
Diabetic ketoacidosis assessment
Differences in rates of diabetic ketoacidosis defined as Blood pH \<7.3 in investigative arms.
Time frame: 12 months