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Trial · Interventional

CompletedPhase 2Results postedRegistry data

ADJUnct Semaglutide Treatment in Type 1 Diabetes

Short name ADJUST-T1D

NCTNCT05537233 (opens ClinicalTrials.gov in a new tab)Other id22388
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
115 participants (actual)
Sponsor
Viral N. Shah · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
11 Apr 2023
Primary completion
6 Aug 2024
Completion
6 Aug 2024
First posted
13 Sept 2022
Last update posted
3 Sept 2025
Conditions
Type 1 Diabetes · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 2

    ADJUST-T1D

    NCT05537233

    11 Apr 2023 to 6 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Semaglutide

    Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy

  • Placebo comparator

    Control

    Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · 26 weeks

    Registry description

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

Secondary outcomes(10)

  1. Change in HbA1c

    Time frame · 26 weeks

    Registry description

    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.

  2. Change in Mean Glucose

    Time frame · 26 weeks

    Registry description

    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.

  3. Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)

    Time frame · 26 weeks

    Registry description

    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.

  4. Percent Time Spent in CGM-measured Glucose >180 mg/dL

    Time frame · 26 weeks

    Registry description

    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.

  5. Percent Time Spent in CGM-measured Glucose >250mg/dL

    Time frame · 26 weeks

    Registry description

    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.

  6. Percent Time Spent in CGM-measured Glucose <70mg/dL

    Time frame · 26 weeks

    Registry description

    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.

  7. Change in CGM Measured Glycemic Variability (Coefficient of Variation)

    Time frame · 26 weeks

    Registry description

    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.

  8. Change in Weight

    Time frame · 26 weeks

    Registry description

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

  9. Change in BMI (Kg/m2)

    Time frame · 26 weeks

    Registry description

    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.

  10. Severe Hypoglycemia

    Time frame · 26 weeks

    Registry description

    SH events in number of patients per group

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 26 weeks

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

GroupValue (Participants)
Semaglutide13
Control0
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· 26 weeks

Change in HbA1c

GroupValue (percentage HbA1c)Spread
Semaglutide-0.70.1
Control-0.40.1
Secondary outcomeLeast squares mean· 26 weeks

Change in Mean Glucose

GroupValue (mg/dL)Spread
Semaglutide-15.72.6
Control-3.62.8
Secondary outcomeLeast squares mean· 26 weeks

Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)

GroupValue (percentage of time)Spread
Semaglutide9.81.7
Control2.91.8
Secondary outcomeLeast squares mean· 26 weeks

Percent Time Spent in CGM-measured Glucose >180 mg/dL

GroupValue (percentage)Spread
Semaglutide-11.11.8
Control-2.71.9
Secondary outcomeLeast squares mean· 26 weeks

Percent Time Spent in CGM-measured Glucose >250mg/dL

GroupValue (percentage)Spread
Semaglutide-5.11.1
Control-0.51.2
Secondary outcomeLeast squares mean· 26 weeks

Percent Time Spent in CGM-measured Glucose <70mg/dL

GroupValue (percentage)Spread
Semaglutide0.10.2
Control0.40.2
Secondary outcomeLeast squares mean· 26 weeks

Change in CGM Measured Glycemic Variability (Coefficient of Variation)

GroupValue (percentage)Spread
Semaglutide-0.30.8
Control0.90.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutideParticipants 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 therapy0 / 361 / 3626 / 36
ControlParticipants 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 therapy0 / 360 / 3611 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

6 results

Semaglutide in Adults with Type 1 Diabetes and Obesity.

Shah et al. 2025NEJM evidencecited by 42

PMID 40550013DOI 10.1056/evidoa2500173PUB-40550013

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: For an eligible subject, all inclusion criteria must be answered "yes" 1. Age ≥18 and ≤ 65 years 2. Patients with clinical diagnosis of T1D diagnosed for at least 12 months 3. Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months 4. Willing to use once weekly semaglutide 5. Willing to share devices (HCL system) data uploads 6. HbA1c \>7.0% and \<10.0% 7. Body mass index ≥30 kg/m2 8. Has current glucagon product to treat severe hypoglycemia 9. Has current ketone meters to check ketones 10. Ability to provide informed consent before any trial-related activities Exclusion Criteria: 1. Age \<18 years and \>65 years 2. HbA1c ≤7.0 % or ≥ 10.0% at screening 3. Less than 12 months of insulin treatment 4. Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system 5. Not willing to share the devices (HCL system) data uploads 6. Non compatible devices (e.g. pump, CGM or smart phones) for data transfer 7. Current use of multiple daily injection or inhaled insulin (Afrezza) 8. Patients with T1D using any glucose lowering medications other than insulin at the time of screening 9. Pregnancy, breast feeding, and positive pregnancy test during screening 10. Women of childbearing age wanting to become pregnant 11. Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period 12. Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (\>4 weeks continuously), during the study period 13. Use of GLP-1RA or weight loss medications in the past 3 month 14. Clinical diagnosis/history of gastroparesis or gastric motility disorders 15. Serum triglycerides \>500 mg/dL 16. Planning for bariatric surgery during the study period 17. eGFR below 45 ml/min/1.73 m\^2 using CKD-EPI formula 18. History of severe hypoglycemia in the previous 3 months 19. History of diabetic ketoacidosis requiring hospitalization in the past 3 months 20. History of allergy to any form of insulin, GLP-1RA or its excipients 21. History of any form of pancreatitis 22. History of stroke, myocardial infarction in the past 3 months 23. History of congestive heart failure class III or IV 24. History of acute or chronic liver disease 25. History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years 26. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma 27. Have a pacemaker, metal implants, or aneurysm clips or weigh \>330 lbs (exclusion only if doing MRI) 28. Use of investigational drugs within 5 half-lives prior to screening 29. Participation to other intervention trials during the study period 30. Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators

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