Could a weekly shot help tame type 1 diabetes?
NCT ID NCT06630585
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a weekly medicine called tirzepatide to usual insulin therapy helps adults with type 1 diabetes control their blood sugar better. About 42 people aged 18-65 who already use an automated insulin pump will take part. The goal is to see if the combination leads to more time with blood sugar in a healthy range.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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DiaCenTRE - Hirslanden Clinique des Grangettes
RECRUITINGChêne-Bougeries, Canton of Geneva, 1224, Switzerland
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Kantonsspital Olten
RECRUITINGOlten, Canton of Solothurn, 4600, Switzerland
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Luzerner Kantonspital
RECRUITINGLucerne, 6000, Switzerland
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Other studies related to the condition(s) this trial covers.
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