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

Recruiting now · Phase 3

Conditions studied: Type 1 Diabetes (T1D)

In brief

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.

Key facts

Study ID

NCT06630585

Run by

University of Bern

People needed

42

Starts

2025-02-14

Expected to finish

2026-06-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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.

You may not qualify if…

• 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).
• 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).

Where it is running

• DiaCenTRE - Hirslanden Clinique des Grangettes — Chêne-Bougeries, Canton of Geneva, Switzerland (enrolling)
• Kantonsspital Olten — Olten, Canton of Solothurn, Switzerland (enrolling)
• Luzerner Kantonspital — Lucerne, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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