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

NCT06630585 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-01947
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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 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

Type 1 Diabetes (T1D)

Keywords

Type 1 diabetes; Adjuvant therapy; Incretins; GIP/GLP-1RA

Outcome Measures

Primary Outcomes (1)

• Change TIR

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

  At week 16 of treatment.

Secondary Outcomes (8)

• Glycated Hemoglobin

  At week 16 of treatment.

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

  At week 16 of treatment.

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

  At week 16 of treatment.

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

  At week 16 of treatment.

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

  At week 16 of treatment.

Other Outcomes (27)

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

  At week 8, 12 and 16 of treatment.

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

  At week 8, 12 and 16 of treatment.

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

  At week 8, 12 and 16 of treatment.

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in this arm will use their standard of care (SoC)

Standard of Care + Drug

EXPERIMENTAL

Participants in this arm will use their standard of care (SoC) plus tirzepatide (titrated to reach a minimum accepted dose.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

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.

Also known as: GIP/GLP-1RA

Standard of Care + Drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Bern: lead
• Kantonsspital Olten: collaborator
• Luzerner Kantonsspital: collaborator
• Clinique des Grangettes, Chêne-Bougeries: collaborator

Study Sites (3)

DiaCenTRE - Hirslanden Clinique des Grangettes

Chêne-Bougeries, Canton of Geneva, 1224, Switzerland

RECRUITING

Kantonsspital Olten

Olten, Canton of Solothurn, 4600, Switzerland

RECRUITING

Luzerner Kantonspital

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Thomas Zueger, PD Dr. med.

  Kantonsspital Olten

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose F Garcia-Tirado, PhD

CONTACT

+41316646109; jose.garcia@unibe.ch

Marie-Aline Gerard, MSc

CONTACT

+41782049811; marie-aline.gerard@dcberne.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)