ZONE

A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes (ZONE)

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Study Description

IRB #

SSU00307287

NCT #

NCT05762107

Principal Investigator

Dr. Subbulaxmi Trikudanathan

Study Location

UW Medicine Diabetes Institute

The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes who have been having low blood sugars at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The study aims to answer whether ZT-01 lowers the amount of low blood sugar happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured. Participants will be asked to participate in up to 7 in-person study visits and 2 phone calls. Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 during one period, and placebo (which looks like the study drug but doesn’t contain the active ingredient) during the other. Study visits will include activities such as reviewing patient health history, measuring vital signs, and collecting blood and urine samples.

Study Details

FAQ Title

Learn more about how you can contribute to important research by volunteering for ZONE.

Who Can Participate?

Inclusion Criteria:

18-75 years old
Has type 1 diabetes for at least 5 years
Is at risk of nocturnal hypoglycemia (if using personal CGM, time below 54 mg/dL at least 1% over previous 4 weeks at screening; if not using personal CGM then recent history suggestive of nocturnal hypoglycemia at screening and time below 54 mg/dL at least 1% over 4 weeks using blinded study CGM during additional screening)
HbA1c at screening </= 10.0%
Body mass index (BMI) at screening >/=18.5 to <33 kg/m2
Participants must use a form of highly effective contraception if they or their partner are capable of becoming pregnant for the duration of the study

Exclusion Criteria:

Has been hospitalized for diabetic ketoacidosis (DKA) more than once within previous 6 months
Has experienced >/= 1 severe hypoglycemia (requiring assistance) during previous 4 weeks or >2 in previous 3 months
Diagnosis of type 2 diabetes, pheochromocytoma, insulinoma, glucagonoma, acromegaly, Cushing’s disease, glycogen storage disease, adrenal insufficiency
Clinically significant kidney disease
Abnormal liver function

Compensation Provided

You will be reimbursed for your time and participation as follows: $100 for each in-person visit, $50 for each telephone visit, $300 for the end-of-treatment visit, and $50 for any unscheduled visits. In addition, you will be reimbursed $24 for parking at each in-person visit. If you complete all scheduled study visits, you may receive up to a total of $1,000.

Contact Study Team

Interested? 👉 Send an email or text message to the contact below

Contact Name: Josephine Stenn

Phone Number: 541-399-4004

Email: jstenn@uw.edu

Contact the Study Team - ZONE

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