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Type 1 Diabetes (T1D)Phase 3AID-JUNCTNCT06630585

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

A Phase 3 study testing Tirzepatide in people with Type 1 Diabetes (T1D), run by University of Bern at 3 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only ~30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes (T1D)
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesSwitzerland
Study dates
14 Feb 2025to Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with diagnosed T1D for at least 12 months.
  • Aged between 18 to 65 years old (inclusive).
  • Currently on AID therapy for at least three months.
  • HbA1C higher or equal to 6.5% and less or equal to 10%.
  • BMI ≥23 kg/m2.
  • Willing to use once-weekly tirzepatide for at least 16 weeks (including four weeks of up-titration and 12 weeks of treatment)
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  • Willing to wear a Dexcom G7 Sensor and share devices (AID) data uploads.
  • 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).
  • 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.
  • 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)
  • An understanding and willingness to follow the protocol and signed informed consent.

Who cannot join

  • History of diabetic ketoacidosis requiring hospitalization in the past six months.
  • History of severe hypoglycemic event (Level 3, defined as seizure or loss of consciousness) in the past six months.
  • Uncontrolled Diabetic retinopathy or maculopathy
  • Severe gastroparesis.
  • Less than 12 months of insulin treatment.
  • Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2 by the CKD-EPI formula(99).
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  • Pregnancy or intention to become pregnant during the trial (See annex 7).
  • Currently breastfeeding or planning to breastfeed.
  • Currently uncontrolled seizure disorder.
  • History of allergy to GIP/GLP-1RAs or its excipients.
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or medullary thyroid carcinoma.
  • Screening calcitonin above or equal to 35 ng/L.
  • Planned any surgery during the study duration.
  • 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.
  • 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).
  • Conditions that may increase the risk of induced hypoglycemia, such as CHF with NYHA Functional Classification III or IV or adrenal insufficiency.
  • Have a history of documented human immunodeficiency virus (HIV) infection.
  • Have an uncontrolled cardiac arrhythmia based on an electrocardiogram (ECG) at the screening time and the investigator's discretion.
  • Cystic fibrosis.
  • Patient with a history of gastric bypass (bariatric) surgery, sleeve gastrectomy, or restrictive bariatric surgery, such as Lap-Band® or gastric banding.
  • Uncontrolled thyroid disease as judged by the investigator
  • 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.
  • 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.
  • Acute or chronic hepatitis other than MASLD.
  • Have a history of symptomatic gallbladder disease within the past two years (unless the participant has had a cholecystectomy to resolve the problem).
  • 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.
  • 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.
  • Treatment with non-insulin glucose-lowering agents other than metformin (on a stable dose 30 days before the study)
  • Weight loss medications in the past three months.
  • 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).
  • Have current treatment with (or history of, within three months before screening) medications that may significantly affect glucose metabolism.
  • Use of investigational drugs within five half-lives before screening.
  • Participation in another study with an investigational drug within the 30 days preceding and during the present study.
  • 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.
  • 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.
  • The enrolment of the investigator, his/her family members, employees, and other dependent persons.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jose F Garcia-Tirado, PhD contact

+41316646109

jose.garcia@unibe.ch

Marie-Aline Gerard, MSc contact

+41782049811

marie-aline.gerard@dcberne.com

Switzerland3 sites, 3 recruiting

  • DiaCenTRE - Hirslanden Clinique des Grangettes

    Chêne-Bougeries, Canton of Geneva, 1224

    Giacomo Gastaldi, PD Dr. med, +41 22 705 11 88, giacomo.gastaldi@diacentre.ch

    Giacomo Gastaldi, PD Dr. med.

    Recruiting

  • Luzerner Kantonspital

    Lucerne, 6000

    Gabriella Gallo, +41412056192, gabriela.gallo@luks.ch

    Stephan Fischli, PD Dr. med.

    Recruiting

  • Kantonsspital Olten

    Olten, Canton of Solothurn, 4600

    Gabriela Schenker, MSc, +41 62 311 44 94, gabriela.schenker@spital.so.ch

    Thomas Zueger, PD Dr. med

    Recruiting

Other trials in Switzerland

About this study

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

Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only ~30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin in T1D.

This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide (GIP/GLP-1RA) to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control.

Read the detailed description

Glycemic control in type 1 diabetes (T1D) remains a challenge, with ~30% of adults achieving an A1c target of 7%. The glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as a promising therapy in T1D. Retrospective studies have shown patients with T1D can significantly improve glycemic control with a reduction in insulin dose and body weight when long-acting GLP-1RAs or GIP/GLP-1RAs are added to insulin therapy. However, randomized controlled trials (RCT) are still lacking.

This is a prospective, randomized, open-label design. The investigators will enroll 42 participants over 18 years of age with confirmed T1D diagnosis ≥6 months, currently on automatic insulin delivery (AID) therapy for at least three months, with A1C ≥6.5% and ≤10%and BMI ≥23 kg/m2. Participants will be randomized in a 1:1 ratio to either tirzepatide 5.0 mg or continue with the Standard of Care (SoC) for 12 weeks (after a titration phase with the lowest dose of 2.5 mg). The primary endpoint is continuous glucose monitoring (CGM) percent time spent between 3.9 and 10.0 mmol/L (TIR) from baseline to follow-up after 12 weeks of treatment. Secondary endpoints include the change in 24/7 CGM percent time \>10.0 mmol/L, 24/7 CGM percent time \>13.9 mmol/L, 24/7 CGM percent time \<3.9 mmol/L, 24/7 CGM percent time \<3.0 mmol/L and the change in body mass index (BMI).

This is the first prospective study to investigate the efficacy and safety of tirzepatide (GIP/GLP1-RAs) as an adjuvant therapy to AID. This study may contribute unique data to significantly improving glucose outcomes, reducing the T1D burden, improving the quality of life, and re-directing attention to further treatment in T1D beyond insulin therapies.

Being tested
Tirzepatide
Keywords
Type 1 diabetes, Adjuvant therapy, Incretins, GIP/GLP-1RA
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called GIP/GLP-1RA

    Tirzepatide is a clear, colorless to slightly yellow solution available in cartons containing four pre-filled single-dose pens or one single-dose vial: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in a single-dose pen or vial.

    In this study, the investigators will start with the recommended starting dosage of tirzepatide: 2.5 mg injected subcutaneously once weekly (for four weeks). After four weeks, the dosage will be increased to 5 mg once weekly injected subcutaneously for 12 weeks.

Study groups in NCT06630585
Study groupRoleWhat they receive
Standard of CareNo interventionParticipants in this arm will use their standard of care (SoC)
Standard of Care + DrugExperimentalParticipants in this arm will use their standard of care (SoC) plus tirzepatide (titrated to reach a minimum accepted dose.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change TIR

    Mean difference in 24/7 CGM percentage time spent between 3.9 and 10 mmol/L (TIR) between groups.

    Measured: At week 16 of treatment.

Secondary outcomes (8)

  1. Glycated Hemoglobin

    Mean difference between groups Glycated Hemoglobin.

    Measured: At week 16 of treatment.

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

    Mean difference between groups in CGM-measured TIR between 0700 and 2300 (TIR7-23).

    Measured: At week 16 of treatment.

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

    Mean difference between groups in CGM-measured time in the tight range (TTR, 3.9-7.8 mmol/L).

    Measured: At week 16 of treatment.

  4. 24/7 CGM-measured percent time >10.0 mmol/L

    Mean difference between groups in 24/7 CGM-measured percent time >10.0 mmol/L

    Measured: At week 16 of treatment.

  5. 24/7 CGM-measured percent time >13.9 mmol/L

    Mean difference between groups in 24/7 CGM-measured percent time >13.9 mmol/L

    Measured: At week 16 of treatment.

  6. 24/7 CGM-measured percent time <3.9 mmol/L

    Mean difference between groups in 24/7 CGM-measured percent time <3.9 mmol/L

    Measured: at week 16 of treatment

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

    Mean difference between groups in 24/7 CGM-measured percent time <3.0 mmol/L

    Measured: At week 16 of treatment.

  8. 24/7 Total Daily Insulin (TDI)

    Mean difference between in 24/7 Total Daily Insulin (TDI)

    Measured: At week 16 of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start14 Feb 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630585
Sponsor's protocol ID
2024-01947
Acronym
AID-JUNCT
Status last verified
Jan 2026
First submitted
3 Oct 2024
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Type 1 Diabetes (T1D), run by University of Bern at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose F Garcia-Tirado, PhD (+41316646109, jose.garcia@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change TIR (time frame: At week 16 of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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