Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

ConditionType 1 Diabetes Mellitus

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorVictor Chang Cardiac Research Institute

About this trial

This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-70 years

BMI ≥ 25 kg/m2

HbA1c ≤ 9.0%

insulin delivery using an automated insulin delivery system

Disqualifiers

TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; systemic steroids, antipsychotics, in the last 6 weeks.

Hypoglycemic unawareness or severe hypoglycemia last 6 months.

History of seizure disorder.

History of weight loss surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

Tirzepatide 2.5mg weekly
Drug
Tirzepatide 2.5 mg/0.5 mL solution for injection vial or pre-filled pen. Each vial/ pre-filled pen contains tirzepatide 2.5 mg in 0.5 mL solution (2.5mg in 0.6mL if Kwikpen) Tirzepatide will be administered by drawing up into a syringe, then administering by subcutaneous injection weekly by study nurses.
Placebo injection (normal saline)
Drug
Placebo will be given as 0.5mL normal saline (if comparator against vial or pre-filled pen), or 0.6mL (if comparator against Mounjaro Kwikpen), drawn up into a syringe and administered by subcutaneous injection weekly by study nurses.

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Tirzepatide 2.5mg weeklyExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Whole-body insulin sensitivity

Change in insulin sensitivity from baseline, assessed using the hyperinsulinemic-euglycemic clamp (60 mU/m2/min)

Time frame

6 weeks

Secondary outcomes

Prandial glucagon secretion

Change from baseline glucagon area under the curve (AUC) during mixed meal tolerance test (MMTT)

Time frame

6 weeks

Glucagon response to hypoglycemia

Change from baseline glucagon AUC after glucose nadir as measured during the hyperinsulinemic hypoglycemic clamp

Time frame

6 weeks

% Time level 2 hypoglycemia

Change from baseline % time level 2 hypoglycemia (defined by glucose \< 54 mg/dL \[\<3.0 mmol/L\]) as measured by continuous glucose monitoring

Time frame

6 weeks

% Time level 1 hypoglycemia

Change from baseline % time level 1 hypoglycemia (defined by glucose \< 70 mg/dL \[3.9 mmol/L\] and ≥ 54 mg/dL \[3.0 mmol/L\]) as measured by continuous glucose monitoring

Time frame

6 weeks

Other outcomes

Diabetes Treatment Satisfaction

Change from baseline diabetes treatment satisfaction, as measured by questionnaire (DTSQ)

Time frame

6 weeks

Metanephrine response to hypoglycemia

Change from baseline peak metanephrine after glucose nadir as measured during the hyperinsulinemic hypoglycemic clamp

Time frame

6 weeks

Normetanephrine response to hypoglycemia

Change from baseline peak normetanephrine after glucose nadir as measured during the hyperinsulinemic hypoglycemic clamp

Time frame

6 weeks

Growth hormone response to hypoglycemia

Change from baseline peak growth hormone after glucose nadir as measured during the hyperinsulinemic hypoglycemic clamp

Time frame

6 weeks

Sponsors and contacts

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

Victor Chang Cardiac Research Institute

Lead sponsor

Source ClinicalTrials.gov

Apply now