Trial Outcomes & Findings for ADJUnct Semaglutide Treatment in Type 1 Diabetes (NCT NCT05537233)

Results Overview

Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

115 participants

Primary outcome timeframe

26 weeks

Results posted on

2025-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Semaglutide Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Overall Study STARTED	36	36
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ADJUnct Semaglutide Treatment in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy	Total n=72 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 11.6 • n=5 Participants	38.9 years STANDARD_DEVIATION 13.1 • n=7 Participants	40 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
body mass index	34.7 kg/m2 STANDARD_DEVIATION 3.9 • n=5 Participants	36.0 kg/m2 STANDARD_DEVIATION 5.2 • n=7 Participants	35 kg/m2 STANDARD_DEVIATION 4.5 • n=5 Participants
HbA1c	7.8 % STANDARD_DEVIATION 0.6 • n=5 Participants	7.7 % STANDARD_DEVIATION 0.6 • n=7 Participants	7.8 % STANDARD_DEVIATION 0.6 • n=5 Participants
Diabetes Duration	23.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	21.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	23 years STANDARD_DEVIATION 11 • n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
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	13 Participants	0 Participants

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Change in HbA1c	-0.7 percentage HbA1c Standard Error 0.1	-0.4 percentage HbA1c Standard Error 0.1

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Change in Mean Glucose	-15.7 mg/dL Standard Error 2.6	-3.6 mg/dL Standard Error 2.8

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)	9.8 percentage of time Standard Error 1.7	2.9 percentage of time Standard Error 1.8

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Percent Time Spent in CGM-measured Glucose >180 mg/dL	-11.1 percentage Standard Error 1.8	-2.7 percentage Standard Error 1.9

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Percent Time Spent in CGM-measured Glucose >250mg/dL	-5.1 percentage Standard Error 1.1	-0.5 percentage Standard Error 1.2

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Percent Time Spent in CGM-measured Glucose <70mg/dL	0.1 percentage Standard Error 0.2	0.4 percentage Standard Error 0.2

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Change in CGM Measured Glycemic Variability (Coefficient of Variation)	-0.3 percentage Standard Error 0.8	0.9 percentage Standard Error 0.9

SECONDARY outcome

Timeframe: 26 weeks

The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Change in Weight	-9.2 kg Standard Error 0.7	-0.4 kg Standard Error 0.6

SECONDARY outcome

Timeframe: 26 weeks

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.

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Change in BMI (Kg/m2)	-3.3 kg/m2 Standard Error 0.3	-0.2 kg/m2 Standard Error 0.2

SECONDARY outcome

Timeframe: 26 weeks

SH events in number of patients per group

Outcome measures

Outcome measures
Measure	Semaglutide n=36 Participants Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 Participants Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Severe Hypoglycemia	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from baseline to 26 weeks will be compared by randomization group using an ITT analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

proportion (N, %) of participants achieving HbA1c \<7% between two groups over 26 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

proportion (N, %) of participants achieving HbA1c \<7.5% between two groups over 26 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

HbA1c improvement from baseline to 26 weeks between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

proportion of participants with HbA1c improvement of \>0.4% from baseline between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving TIR \>70% between two groups over 26 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving TITR (time in 70-140 mg/dL) \>50% between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving TIR \>80% between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving TITR (time in 70-140 mg/dL) \>60% between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Numbers of events of CGM glucose \<70 mg/dL lasting for at least 15 minutes between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Numbers of events of CGM glucose \<54mg/dL lasting for at least 15 minutes between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in TDD between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving weight loss ≥5% from baseline between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving weight loss ≥10% from baseline between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving BMI \<30 kg/m2 between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving BMI \<25 kg/m2 between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

change in SBP (mmHg) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

change in DBP (mmHg) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

change in pulse pressure between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in triglyceride/HDL ratio between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in brachial arterial distensibility between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in carotid intima media thickness (cIMT) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in femoral to carotid pulse wave velocity (m/s) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in ACR between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in QOL between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in total boluses per day (frequency of boluses per day) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in Carbohydrate intake per day (grams/day) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in total bolus insulin per day (units per day and U/Kg/day) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in eGFR using CKD-EPI between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in Fib-4 score between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in HSI (hepatic steatosis index) between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in MRI measured pulse wave velocity and longitudinal strain between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in LDL-C between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in TC between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in TG between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in HDL-C between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants with ACR \<30 at 26 weeks between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Proportion of participants with change in ACR from \>30 to \<30 between two groups

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Achievement of primary outcomes by baseline BMI (BMI \<35 vs \>35)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Achievement of primary outcomes by baseline A1c (A1c \<7.5% vs \>7.5%)

Outcome measures

Outcome data not reported

Adverse Events

Semaglutide

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Semaglutide n=36 participants at risk Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 participants at risk Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Gastrointestinal disorders Nausea & vomiting	2.8% 1/36 • Number of events 1 • from signing consent from till end of the study (i.e 26 weeks)	0.00% 0/36 • from signing consent from till end of the study (i.e 26 weeks)

Other adverse events

Other adverse events
Measure	Semaglutide n=36 participants at risk Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy	Control n=36 participants at risk Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy
Gastrointestinal disorders Gastrointestinal events	52.8% 19/36 • Number of events 57 • from signing consent from till end of the study (i.e 26 weeks)	25.0% 9/36 • Number of events 13 • from signing consent from till end of the study (i.e 26 weeks)
Infections and infestations Upper respitory infectin	8.3% 3/36 • Number of events 4 • from signing consent from till end of the study (i.e 26 weeks)	2.8% 1/36 • Number of events 1 • from signing consent from till end of the study (i.e 26 weeks)
Infections and infestations COVID-19	11.1% 4/36 • Number of events 4 • from signing consent from till end of the study (i.e 26 weeks)	2.8% 1/36 • Number of events 1 • from signing consent from till end of the study (i.e 26 weeks)

Additional Information

Viral N Shah, MD

Indiana University School of Medicine

Phone: 317-278-6017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place