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Clinical Trial Details

Trial ID: L7166
Source ID: NCT05537233
Associated Drug: Semaglutide
Title: ADJUnct Semaglutide Treatment in Type 1 Diabetes
Acronym: ADJUST-T1D
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Obesity
Interventions: DRUG: Semaglutide|DRUG: Placebo
Outcome Measures: Primary: 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, The primary endpoint (differences in proportion of patients achieving composite outcomes) will be compared, including the proportion of study participants achieving a reduction in body weight of 5% or more between 4 and 26 weeks and achieving TIR \>70% and TBR of \<4% at 26 weeks. This comparison between the proportion meeting the composite endpoint will be examined while adjusting for pre-specified covariates, baseline A1c and BMI. Baseline A1c is known to affect TIR (better improvement in TIR in those with higher A1c). Similarly, higher BMI may affect weight loss. Therefore, the investigator decided to use these covariates for adjustment. Sustain 7 post hoc analysis suggested that efficacy of semaglutide on glycemic control and weight loss remains the same regardless of baseline age, diabetes duration or sex. Therefore, the investigator did not include those variables in the pre-specified adjustment., 26 weeks | Secondary: Change in HbA1c, HbA1c will be measured at a central laboratory and change in Hba1c from 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 26 weeks|Change in mean glucose, Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.weeks will be compared by randomization group using intention to treat (ITT) analysis., 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 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 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 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 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 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 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 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 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 4 weeks to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis., 26 weeks|Change in patient reported quality of life, Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from 4 to 26 weeks will be compared by randomization group using an ITT analysis., 26 weeks|Change in weight, The change in kg of body weight from 4 to 26 weeks will be compared by randomization group using an ITT analysis., 26 weeks|Change in BMI (Kg/m2), Change in body mass index (BMI) calculated as kg body weight per meter squared of height from 4 to 26 weeks will be compared by randomization group using an ITT analysis., 26 weeks|Severe Hypoglycemia and diabetic ketoacidosis events, SH and DKA events will be calculated as an event rate per 1,000 persons per year and will be compared between the two treatment groups using Poisson regression with follow-up time as an offset, 26 weeks | Other: Proportion of participants with HbA1c <7%, proportion (N, %) of participants achieving HbA1c \<7% between two groups over 26 weeks, 26 weeks|Proportion of participants with HbA1c <7.5%, proportion (N, %) of participants achieving HbA1c \<7.5% between two groups over 26 weeks, 26 weeks|HbA1c improvement, HbA1c improvement from baseline to 26 weeks between two groups, 26 weeks|HbA1c improvement of >0.4% from baseline, proportion of participants with HbA1c improvement of \>0.4% from baseline between two groups, 26 weeks|Proportion of participants achieving TIR >70%, Proportion of participants achieving TIR \>70% between two groups over 26 weeks, 26 weeks|Proportion of participants achieving TITR >50%, Proportion of participants achieving TITR (time in 70-140 mg/dL) \>50% between two groups, 26 weeks|Proportion of participants achieving TIR >80%, Proportion of participants achieving TIR \>80% between two groups, 26 weeks|Proportion of participants achieving TITR >60%, Proportion of participants achieving TITR (time in 70-140 mg/dL) \>60% between two groups, 26 weeks|Number of TBR<70 events, Numbers of events of CGM glucose \<70 mg/dL lasting for at least 15 minutes between two groups, 26 weeks|Number of TBR <54 events, Numbers of events of CGM glucose \<54mg/dL lasting for at least 15 minutes between two groups, 26 weeks|Change in total daily dose of insulin (TDD, Units per day and U/Kg/Day), Change in TDD between two groups, 26 weeks|Proportion achieving weight loss ≥5%, Proportion of participants achieving weight loss ≥5% from baseline between two groups, 26 weeks|Proportion achieving weight loss ≥10%, Proportion of participants achieving weight loss ≥10% from baseline between two groups, 26 weeks|Proportion of achieving BMI <30 kg/m2, Proportion of participants achieving BMI \<30 kg/m2 between two groups, 26 weeks|Proportion of achieving BMI <25 kg/m2, Proportion of participants achieving BMI \<25 kg/m2 between two groups, 26 weeks|Change in systolic blood pressure (SBP), change in SBP (mmHg) between two groups, 26 weeks|Change in diastolic blood pressure (DBP), change in DBP (mmHg) between two groups, 26 weeks|Change in pulse pressure, change in pulse pressure between two groups, 26 weeks|Change in triglyceride/HDL ratio, Change in triglyceride/HDL ratio between two groups, 26 weeks|Change in Brach D, Change in brachial arterial distensibility between two groups, 26 weeks|Change in carotid intima media thickness (cIMT), Change in carotid intima media thickness (cIMT) between two groups, 26 weeks|Change in femoral to carotid pulse wave velocity (m/s), Change in femoral to carotid pulse wave velocity (m/s) between two groups, 26 weeks|Change in urine albumin to creatinine ratio (ACR), Change in ACR between two groups, 26 weeks|Quality of life (Diabetes Dependent QOL), Change in QOL between two groups, 26 weeks|Change in CGM metrics by daytime vs nighttime, Change in CGM metrics (TIR, TITR, mean glucose, TBR, TAR \>180, SD, CV) by daytime (6 AM to \<11 PM) and nighttime (11 PM to \<6 AM) between two groups, 26 weeks|AID setting adjustment, Defined any adjustment in settings by provider or patient per person over the study period by two groups (number of adjustments (N) during trial) between two groups, 26 weeks|Change in basal insulin per day, Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups, 26 weeks|Change in total boluses per day, Change in total boluses per day (frequency of boluses per day) between two groups, 26 weeks|Achievement of primary outcome and key secondary outcomes by types of AID systems, Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems, 26 weeks|Change in Carbohydrate intake per day (grams/day), Change in Carbohydrate intake per day (grams/day) between two groups, 26 weeks|Change in total bolus insulin per day, Change in total bolus insulin per day (units per day and U/Kg/day) between two groups, 26 weeks|Change in eGFR, Change in eGFR using CKD-EPI between two groups, 26 weeks|Change in Fib-4 score, Change in Fib-4 score between two groups, 26 weeks|Change in HSI (hepatic steatosis index), Change in HSI (hepatic steatosis index) between two groups, 26 weeks|Change in MRI measured pulse wave velocity and longitudinal strain, Change in MRI measured pulse wave velocity and longitudinal strain between two groups, 26 weeks|Change in LDL-C, Change in LDL-C between two groups, 26 weeks|Change in TC, Change in TC between two groups, 26 weeks|Change in TG, Change in TG between two groups, 26 weeks|Change in HDL-C, Change in HDL-C between two groups, 26 weeks|Proportion with ACR <30 at 26 weeks, Proportion of participants with ACR \<30 at 26 weeks between two groups, 26 weeks|Proportion with change in ACR from >30 to <30, Proportion of participants with change in ACR from \>30 to \<30 between two groups, 26 weeks|Achievement of primary outcomes by baseline BMI (BMI <35 vs >35), Achievement of primary outcomes by baseline BMI (BMI \<35 vs \>35), 26 weeks|Achievement of primary outcomes by baseline A1c (A1c <7.5% vs >7.5%), Achievement of primary outcomes by baseline A1c (A1c \<7.5% vs \>7.5%), 26 weeks
Sponsor/Collaborators: Sponsor: Viral N. Shah | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 115
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-11
Completion Date: 2024-08-06
Results First Posted:
Last Update Posted: 2025-03-30
Locations: Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States|Iowa Diabetes Research Center, West Des Moines, Iowa, 50265, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Harold Schnitzer Diabetes Health Center, Portland, Oregon, 97239, United States
URL: https://clinicaltrials.gov/show/NCT05537233