GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes
ConditionType 1 Diabetes (T1D)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Bern
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugTirzepatide 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Standard of Care + DrugExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change TIR
Mean difference in 24/7 CGM percentage time spent between 3.9 and 10 mmol/L (TIR) between groups.
Time frame
At week 16 of treatment.Secondary outcomes
1
Glycated Hemoglobin
Mean difference between groups Glycated Hemoglobin.
Time frame
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).
Time frame
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).
Time frame
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
Time frame
At week 16 of treatment.Other outcomes
1
CGM-measured TIR between 0700 and 2300 (TIR7-23)
Mean difference between groups in CGM-measured TIR between 0700 and 2300 (TIR7-23).
Time frame
At week 8, 12 and 16 of treatment.2
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
Time frame
At week 8, 12 and 16 of treatment.3
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
Time frame
At week 8, 12 and 16 of treatment.4
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
Time frame
At week 8, 12 and 16 of treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bern
Lead sponsor
Kantonsspital Olten
Collaborator
Luzerner Kantonsspital
Collaborator
Clinique des Grangettes, Chêne-Bougeries
Collaborator
Source ClinicalTrials.gov