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RecruitingPhase 2

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

A Phase 2a Randomized, Double-blind, Placebo-controlled, Multiple-dose, Crossover Study of the Effect of ZT-01 on Frequency of Nocturnal Hypoglycemia in Type 1 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits, 4 visits
  • Time periods mentioned: 16 weeks
  • Procedures mentioned: Phone or video check-ins, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks."
  • "They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ZT-01 can reduce low blood sugar at night in adults with type 1 diabetes who have nighttime lows. It will also check the drug’s safety and its effects on blood sugar. Participants will inject ZT-01 before bed during one 4-week period and a placebo, which has no active drug, during another.

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 (T1D) who have been having low blood sugars ("hypos") 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 main questions this trial aims to answer are whether ZT-01 lowers the number of hypos 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 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 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day. If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit. Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart. Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 1 diabetes for at least 5 years.
  • Be at risk for low blood sugar at night. A continuous glucose monitor (CGM) must show blood sugar below 54 mg/dL for at least 1% of a 4-week period. If you do not use your own CGM, you must also have a recent history suggesting nighttime lows and wear a study CGM for this check.
  • Have an HbA1c of 10.0% or less at screening. This blood test shows your average blood sugar over the past few months.
  • Have a body mass index (BMI) of at least 18.5 but below 33 at screening. BMI is a measure based on height and weight.

Who can't join

  • Have been hospitalized more than once in the past 6 months for diabetic ketoacidosis (DKA), a dangerous buildup of acids in the blood.
  • Have had low blood sugar that required help from someone else at least once in the past 4 weeks, or more than twice in the past 3 months.
  • Have type 2 diabetes.
  • Have pheochromocytoma, insulinoma, or glucagonoma—tumors that make certain hormones.
  • Have acromegaly or Cushing’s disease—conditions that cause too much of certain hormones.
  • Have glycogen storage disease, which affects how the body stores or uses sugar, or adrenal insufficiency, which means the adrenal glands make too little hormone.
  • Have significant kidney disease.
  • Have abnormal liver function.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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

Study sites (38)

AL

AR

CA

CO

CT

FL

GA

IL

IN

KS

LA

MD

MI

NC

NE

NV

NY

OH

PA

TN

TX

UT

WA

  • University of Washington Diabetes Institute - Clinical Research Unit · Seattle, WA 98109Caelan Ruiz · Study contact · 2066166858 · ccr20@uw.eduSubbulaxmi Trikudanathan, MD · Principal investigatorMore trials in Seattle