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AID-JUNCT

RecruitingPhase 3

GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes

GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes: A Prospective, Randomized, Clinical Study - The AID-JUNCT Trial

Lead sponsor

University of Bern

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

3

Recruiting sites

3

Enrollment

42

estimated

Study population

Type 1 diabetes

Key I/E criterion

BMI ≥23

Primary endpoint

CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06630585
Org study ID2024-01947

Timeline

Milestones

Study first posted2024-10-08actual
Study start2025-02-14actual
Last update posted2026-01-26actual
Primary completion2026-06estimated (month precision)
Study completion2026-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Participants with diagnosed T1D for at least 12 months.

2. Aged between 18 to 65 years old (inclusive).

3. Currently on AID therapy for at least three months.

4. HbA1C higher or equal to 6.5% and less or equal to 10%.

5. BMI ≥23 kg/m2.

6. Willing to use once-weekly tirzepatide for at least 16 weeks (including four weeks of up-titration and 12 weeks of treatment)

7. Willing to wear a Dexcom G7 Sensor and share devices (AID) data uploads.

8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, pramlintide, DPP-4 inhibitors, sodium-glucose cotransporter 2 inhibitors [SGLT2 inhibitors], and nutraceuticals).

9. A stable weight (± 5%) in the last 90 days or more before the screening and agree to not initiate a diet and/or exercise program during the study to reduce body weight other than the lifestyle and dietary measures for diabetes treatment.

10. Females with childbearing potential and males (if apply) must be willing to use reliable contraceptive methods (for the contraceptives study guidelines. See Annex 7 of the protocol)

11. An understanding and willingness to follow the protocol and signed informed consent.

Exclusion criteria

1. History of diabetic ketoacidosis requiring hospitalization in the past six months.

2. History of severe hypoglycemic event (Level 3, defined as seizure or loss of consciousness) in the past six months.

3. Uncontrolled Diabetic retinopathy or maculopathy

4. Severe gastroparesis.

5. Less than 12 months of insulin treatment.

6. Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2 by the CKD-EPI formula(99).

7. Pregnancy or intention to become pregnant during the trial (See annex 7).

8. Currently breastfeeding or planning to breastfeed.

9. Currently uncontrolled seizure disorder.

10. History of allergy to GIP/GLP-1RAs or its excipients.

11. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or medullary thyroid carcinoma.

12. Screening calcitonin above or equal to 35 ng/L.

13. Planned any surgery during the study duration.

14. Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and/or diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted.

15. Personal history of one of the following cardiovascular conditions (within two months before the screening): acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF).

16. Conditions that may increase the risk of induced hypoglycemia, such as CHF with NYHA Functional Classification III or IV or adrenal insufficiency.

17. Have a history of documented human immunodeficiency virus (HIV) infection.

18. Have an uncontrolled cardiac arrhythmia based on an electrocardiogram (ECG) at the screening time and the investigator's discretion.

19. Cystic fibrosis.

20. Patient with a history of gastric bypass (bariatric) surgery, sleeve gastrectomy, or restrictive bariatric surgery, such as Lap-Band® or gastric banding.

21. Uncontrolled thyroid disease as judged by the investigator

22. Serum triglycerides higher than 5.7 mmol/L (500 mg/dL) at the screening. If a participant is on lipid-lowering therapies, doses must be stable for 30 days before screening.

23. Personal history of acute or chronic pancreatitis. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has had a cholecystectomy to resolve the problem.

24. Acute or chronic hepatitis other than MASLD.

25. Have a history of symptomatic gallbladder disease within the past two years (unless the participant has had a cholecystectomy to resolve the problem).

26. History of malignancy requiring chemotherapy, surgery, or radiation (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) in the previous five years.

27. Active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (such as known drug or alcohol abuse, diagnosed eating disorder, or any other uncontrolled psychiatric disorder) that, in the investigator's opinion, may preclude the participant from following and completing the protocol.

28. Treatment with non-insulin glucose-lowering agents other than metformin (on a stable dose 30 days before the study)

29. Weight loss medications in the past three months.

30. Participants who are anticipated to receive, are receiving, or have received within three months before the screening (more than two weeks and more or equal to 10mg prednisolone-equivalent) chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations).

31. Have current treatment with (or history of, within three months before screening) medications that may significantly affect glucose metabolism.

32. Use of investigational drugs within five half-lives before screening.

33. Participation in another study with an investigational drug within the 30 days preceding and during the present study.

34. Current enrollment in another clinical trial unless approved by the investigator of both studies and if the clinical trial is a non-interventional registry trial.

35. Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with following study procedures or the interpretation of data, as judged by the study physician at screening.

36. The enrolment of the investigator, his/her family members, employees, and other dependent persons.

Endpoints (36)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
16
Weight & body composition
9
Cardiometabolic biomarkers
7
MASH / liver
2
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

9 endpoints
Other/protocol endpoint

Body Weight (BW)

Time frame:At week 16 of treatment.

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Waist Circumference (WC)

Time frame:At week 16 of treatment

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Hip circumference

Time frame:At week 16 of treatment.

change from baseline, improvement

Other/protocol endpoint

Waist-to-hip ratio

Time frame:At week 16 of treatment.

change from baseline, improvement

Other/protocol endpoint

% Fat mass

Time frame:At week 16 of treatment.

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Fat mass index

Time frame:At week 16 of treatment.

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Visceral adipose tissue

Time frame:At week 16 of treatment.

Visceral fat, change

change from baseline, improvement

Other/protocol endpoint

Lean Mass Index

Time frame:At week 16 of treatment.

Lean mass

change from baseline, improvement

Other/protocol endpoint

Appendicular Lean Mass Index

Time frame:At week 16 of treatment.

change from baseline, improvement

Glycemic / diabetes

16 endpoints
Primary/protocol endpoint

Change TIR

Time frame:At week 16 of treatment.

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Glycated Hemoglobin

Time frame:At week 16 of treatment.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

CGM-measured TIR between 0700 and 2300 (TIR7-23)

Time frame:At week 16 of treatment.

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

CGM-measured time in the tight range (TTR, 3.9-7.8 mmol/L)

Time frame:At week 16 of treatment.

descriptive, improvement

Secondary/protocol endpoint

24/7 CGM-measured percent time >10.0 mmol/L

Time frame:At week 16 of treatment.

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

24/7 CGM-measured percent time >13.9 mmol/L

Time frame:At week 16 of treatment.

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

24/7 CGM-measured percent time <3.9 mmol/L

Time frame:at week 16 of treatment

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

24/7 CGM-measured percent time <3.0 mmol/L

Time frame:At week 16 of treatment.

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

24/7 Total Daily Insulin (TDI)

Time frame:At week 16 of treatment.

change from baseline, improvement

Other/protocol endpoint

CGM-measured TIR between 0700 and 2300 (TIR7-23)

Time frame:At week 8, 12 and 16 of treatment.

CGM time-in-range

change from baseline, improvement

Other/protocol endpoint

24/7 CGM-measured percent time >10.0 mmol/L

Time frame:At week 8, 12 and 16 of treatment.

CGM time-above-range

descriptive, improvement

Other/protocol endpoint

24/7 CGM-measured percent time >13.9 mmol/L

Time frame:At week 8, 12 and 16 of treatment.

CGM time-above-range

percent change from baseline, improvement

Other/protocol endpoint

24/7 CGM-measured percent time <3.9 mmol/L

Time frame:At week 8, 12 and 16 of treatment.

CGM time-below-range

percent change from baseline, improvement

Other/protocol endpoint

CGM-measured glucose variability (CV)

Time frame:At week 8, 12 and 16 of treatment.

descriptive, improvement

Other/protocol endpoint

24/7 Total Daily Insulin (TDI)

Time frame:At week 8, 12 and 16 of treatment.

change from baseline, improvement

Other/protocol endpoint/low confidence

24/7 Total Daily Bolus (TDBo)

Time frame:At week 8, 12 and 16 of treatment.

change from baseline, improvement

MASH / liver

2 endpoints
Other/protocol endpoint

Hepatic Steatosis Index (HSI)

Time frame:At week 16 of treatment.

change from baseline, improvement

Other/protocol endpoint

Fibrosis Score (FIB-4)

Time frame:At week 16 of treatment.

change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint

Albumin to Creatinine Ratio

Time frame:At week 16 of treatment.

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

7 endpoints
Other/protocol endpoint

Cholesterol LDL

Time frame:At week 16 of treatment.

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other/protocol endpoint

Cholesterol HDL

Time frame:At week 16 of treatment.

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Other/protocol endpoint

Cholesterol non-HDL

Time frame:At week 16 of treatment.

Non-HDL cholesterol, change

change from baseline, improvement

Other/protocol endpoint

Triglycerides

Time frame:At week 16 of treatment.

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

TG-glucose index

Time frame:At week 16 of treatment.

change from baseline, improvement

Other/protocol endpoint

Systolic blood pressure

Time frame:At week 16 of treatment.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Diastolic blood pressure

Time frame:At week 16 of treatment.

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

24/7 CGM-measured percent time <3.0 mmol/L

Time frame:At week 8, 12 and 16 of treatment.

CGM time-below-range

percent change from baseline, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.