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Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

ConditionsType 1 Diabetes MellitusOverweight and Obesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRoyal North Shore Hospital

About this trial

This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years at screening

A clinical diagnosis of T1D for at least 12 months at time of screening

Body mass index ≥ 27kg/m2

HbA1c ≤ 10%

Disqualifiers

Age <18 years and >70 years

A clinical diagnosis of diabetes type other than T1D

HbA1c > 10%

Use of GLP-1 receptor agonist within 1 month of study screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Tirzepatide will be self-administered subcutaneously by study participants via an injection. The drug will be taken weekly following the schedule: 4 weeks at 2.5 mg QW, 4 weeks at 5.0 mg QW, 4 weeks at 7.5 mg QW, 4 weeks at 10.0 mg QW, 4 weeks at 12.5 mg QW, 12 weeks at 15 mg QW. Modification of study drug will be performed if the participant is experiencing significant side effects and cannot tolerate the higher dosage of the study drug. In this instance, the study drug dosage will be reduced to the previously tolerated dosage and held at this dose for a further 4 weeks. One further attempt at dose escalation will be undertaken after 4 weeks, at the discretion of the participant and the study investigator. If recurrent side effects are experienced by the participant, the study drug will be returned to the previously tolerated dosage, and the prescription continued at this dosage for the remainder of the study.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Insulin TreatmentNo intervention 0 interventions
Group B: Tirzepatide TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body weight

Percent body weight change (%)

Time frame
32 weeks

Secondary outcomes

1

hbA1c

Change in hbA1c levels (%)

Time frame
32 weeks
2

Time in range

Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))

Time frame
32 weeks
3

Total daily insulin dose

Change in insulin dose (total daily dose, units/kg of body weight)

Time frame
32 weeks
4

Insulin carbohydrate ratio

Change in insulin dose (insulin carbohydrate ratio (units per g))

Time frame
32 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal North Shore Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: