The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.
After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
Semaglutide up to 1 mg per week in addition to standard closed-loop therapy
Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Iowa Diabetes Research Center
West Des Moines, Iowa, United States
Henry Ford Hospital
Detroit, Michigan, United States
Harold Schnitzer Diabetes Health Center
Portland, Oregon, United States
Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group
Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.
Time frame: 26 weeks
Change in HbA1c
HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Change in Mean Glucose
Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)
Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Percent Time Spent in CGM-measured Glucose >180 mg/dL
Percent of time spent in glucose range \>180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Percent Time Spent in CGM-measured Glucose >250mg/dL
Percent of time spent in glucose range \>250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
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Time frame: 26 weeks
Percent Time Spent in CGM-measured Glucose <70mg/dL
Percent of time spent in glucose range \<70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Change in CGM Measured Glycemic Variability (Coefficient of Variation)
Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Time frame: 26 weeks
Change in Weight
The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.
Time frame: 26 weeks
Change in BMI (Kg/m2)
Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis.
Time frame: 26 weeks
Severe Hypoglycemia
SH events in number of patients per group
Time frame: 26 weeks