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Completed

NCT Number: NCT05537233

ADJUnct Semaglutide Treatment in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Davis Center for Diabetes, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For an eligible subject, all inclusion criteria must be answered "yes"

  • Age ≥18 and ≤ 65 years
  • Patients with clinical diagnosis of T1D diagnosed for at least 12 months
  • Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
  • Willing to use once weekly semaglutide
  • Willing to share devices (HCL system) data uploads
  • HbA1c >7.0% and <10.0%
  • Body mass index ≥30 kg/m2
  • Has current glucagon product to treat severe hypoglycemia
  • Has current ketone meters to check ketones
  • Ability to provide informed consent before any trial-related activities

Exclusion criteria

  • Age <18 years and >65 years
  • HbA1c ≤7.0 % or ≥ 10.0% at screening
  • Less than 12 months of insulin treatment
  • Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system
  • Not willing to share the devices (HCL system) data uploads
  • Non compatible devices (e.g. pump, CGM or smart phones) for data transfer
  • Current use of multiple daily injection or inhaled insulin (Afrezza)
  • Patients with T1D using any glucose lowering medications other than insulin at the time of screening
  • Pregnancy, breast feeding, and positive pregnancy test during screening
  • Women of childbearing age wanting to become pregnant
  • Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period
  • Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
  • Use of GLP-1RA or weight loss medications in the past 3 month
  • Clinical diagnosis/history of gastroparesis or gastric motility disorders
  • Serum triglycerides >500 mg/dL
  • Planning for bariatric surgery during the study period
  • eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula
  • History of severe hypoglycemia in the previous 3 months
  • History of diabetic ketoacidosis requiring hospitalization in the past 3 months
  • History of allergy to any form of insulin, GLP-1RA or its excipients
  • History of any form of pancreatitis
  • History of stroke, myocardial infarction in the past 3 months
  • History of congestive heart failure class III or IV
  • History of acute or chronic liver disease
  • History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma
  • Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusion only if doing MRI)
  • Use of investigational drugs within 5 half-lives prior to screening
  • Participation to other intervention trials during the study period
  • Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators

Treatment and study plan

semaglutide

Drug

Semaglutide up to 1 mg per week in addition to standard closed-loop therapy

Placebo

Drug

Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Primary outcomes

  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

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

Secondary outcomes

  1. Change in HbA1c

    Time frame: 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.

  2. Change in Mean Glucose

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  8. Change in Weight

    Time frame: 26 weeks

    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

    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

    SH events in number of patients per group

Other outcomes

  1. Change in Patient Reported Quality of Life

    Time frame: 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.

  2. Proportion of Participants With HbA1c <7%

    Time frame: 26 weeks

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

  3. Proportion of Participants With HbA1c <7.5%

    Time frame: 26 weeks

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

  4. HbA1c Improvement

    Time frame: 26 weeks

    HbA1c improvement from baseline to 26 weeks between two groups

  5. HbA1c Improvement of >0.4% From Baseline

    Time frame: 26 weeks

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

  6. Proportion of Participants Achieving TIR >70%

    Time frame: 26 weeks

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

  7. Proportion of Participants Achieving TITR >50%

    Time frame: 26 weeks

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

  8. Proportion of Participants Achieving TIR >80%

    Time frame: 26 weeks

    Proportion of participants achieving TIR >80% between two groups

  9. Proportion of Participants Achieving TITR >60%

    Time frame: 26 weeks

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

  10. Number of TBR<70 Events

    Time frame: 26 weeks

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

  11. Number of TBR <54 Events

    Time frame: 26 weeks

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

  12. Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day)

    Time frame: 26 weeks

    Change in TDD between two groups

  13. Proportion Achieving Weight Loss ≥5%

    Time frame: 26 weeks

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

  14. Proportion Achieving Weight Loss ≥10%

    Time frame: 26 weeks

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

  15. Proportion of Achieving BMI <30 kg/m2

    Time frame: 26 weeks

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

  16. Proportion of Achieving BMI <25 kg/m2

    Time frame: 26 weeks

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

  17. Change in Systolic Blood Pressure (SBP)

    Time frame: 26 weeks

    change in SBP (mmHg) between two groups

  18. Change in Diastolic Blood Pressure (DBP)

    Time frame: 26 weeks

    change in DBP (mmHg) between two groups

  19. Change in Pulse Pressure

    Time frame: 26 weeks

    change in pulse pressure between two groups

  20. Change in Triglyceride/HDL Ratio

    Time frame: 26 weeks

    Change in triglyceride/HDL ratio between two groups

  21. Change in Brach D

    Time frame: 26 weeks

    Change in brachial arterial distensibility between two groups

  22. Change in Carotid Intima Media Thickness (cIMT)

    Time frame: 26 weeks

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

  23. Change in Femoral to Carotid Pulse Wave Velocity (m/s)

    Time frame: 26 weeks

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

  24. Change in Urine Albumin to Creatinine Ratio (ACR)

    Time frame: 26 weeks

    Change in ACR between two groups

  25. Quality of Life (Diabetes Dependent QOL)

    Time frame: 26 weeks

    Change in QOL between two groups

  26. Change in CGM Metrics by Daytime vs Nighttime

    Time frame: 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

  27. AID Setting Adjustment

    Time frame: 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

  28. Change in Basal Insulin Per Day

    Time frame: 26 weeks

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

  29. Change in Total Boluses Per Day

    Time frame: 26 weeks

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

  30. Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems

    Time frame: 26 weeks

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

  31. Change in Carbohydrate Intake Per Day (Grams/Day)

    Time frame: 26 weeks

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

  32. Change in Total Bolus Insulin Per Day

    Time frame: 26 weeks

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

  33. Change in eGFR

    Time frame: 26 weeks

    Change in eGFR using CKD-EPI between two groups

  34. Change in Fib-4 Score

    Time frame: 26 weeks

    Change in Fib-4 score between two groups

  35. Change in HSI (Hepatic Steatosis Index)

    Time frame: 26 weeks

    Change in HSI (hepatic steatosis index) between two groups

  36. Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain

    Time frame: 26 weeks

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

  37. Change in LDL-C

    Time frame: 26 weeks

    Change in LDL-C between two groups

  38. Change in TC

    Time frame: 26 weeks

    Change in TC between two groups

  39. Change in TG

    Time frame: 26 weeks

    Change in TG between two groups

  40. Change in HDL-C

    Time frame: 26 weeks

    Change in HDL-C between two groups

  41. Proportion With ACR <30 at 26 Weeks

    Time frame: 26 weeks

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

  42. Proportion With Change in ACR From >30 to <30

    Time frame: 26 weeks

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

  43. Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35)

    Time frame: 26 weeks

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

  44. Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%)

    Time frame: 26 weeks

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

Sponsors and collaborators

Lead sponsor

Viral N. Shah

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.

Acronym: ADJUST-T1D

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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