Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06630585

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

Led by University of Bern · Updated on 2026-01-26

42

Participants Needed

3

Research Sites

67 weeks

Total Duration

On this page

Sponsors

U

University of Bern

Lead Sponsor

K

Kantonsspital Olten

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 1 diabetes for at least 12 months
  • Aged between 18 and 65 years old
  • Currently using automated insulin delivery therapy for at least three months
  • HbA1C between 6.5% and 10%
  • Body mass index (BMI) of 23 kg/m2 or higher
  • Willing to use once-weekly tirzepatide for at least 16 weeks including a 4-week titration phase
  • Willing to wear a Dexcom G7 Sensor and share insulin delivery device data
  • Willing not to start new non-insulin glucose-lowering medications during the trial
  • Stable weight within ±5% for at least 90 days before screening and agree not to start diet or exercise programs to reduce weight beyond usual diabetes care
  • Females with childbearing potential and males must agree to use reliable contraception
  • Understand and agree to follow the study protocol and sign informed consent
Not Eligible

You will not qualify if you...

  • History of diabetic ketoacidosis requiring hospitalization in the past 6 months
  • Severe hypoglycemia causing seizure or loss of consciousness in the past 6 months
  • Uncontrolled diabetic retinopathy or maculopathy
  • Severe gastroparesis
  • Insulin treatment for less than 12 months
  • Estimated glomerular filtration rate below 30 mL/min/1.73 m2
  • Pregnant, breastfeeding, or planning pregnancy during the trial
  • Uncontrolled seizure disorder
  • Allergy to GIP/GLP-1 receptor agonists or their ingredients
  • Personal or family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Elevated calcitonin levels (≥35 ng/L)
  • Planned surgery during the study period
  • Uncontrolled hypertension or unstable cardiovascular conditions
  • Conditions increasing hypoglycemia risk such as severe heart failure or adrenal insufficiency
  • HIV infection
  • Uncontrolled cardiac arrhythmia
  • Cystic fibrosis
  • History of bariatric surgery
  • Uncontrolled thyroid disease
  • High serum triglycerides (>5.7 mmol/L)
  • History of pancreatitis or symptomatic gallbladder disease within 2 years unless resolved by surgery
  • Acute or chronic hepatitis other than MASLD
  • Recent malignancy requiring treatment
  • Active major depressive disorder or severe psychiatric illness
  • Use of non-insulin glucose-lowering agents other than stable metformin
  • Recent weight loss medications or systemic glucocorticoid therapy
  • Use of medications affecting glucose metabolism
  • Participation in other investigational drug trials recently or currently
  • Significant uncontrolled medical conditions that interfere with study participation
  • Investigator and related persons are excluded from enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

DiaCenTRE - Hirslanden Clinique des Grangettes

Chêne-Bougeries, Canton of Geneva, Switzerland, 1224

Actively Recruiting

2

Kantonsspital Olten

Olten, Canton of Solothurn, Switzerland, 4600

Actively Recruiting

3

Luzerner Kantonspital

Lucerne, Switzerland, 6000

Actively Recruiting

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Research Team

J

Jose F Garcia-Tirado, PhD

CONTACT

M

Marie-Aline Gerard, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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