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

Primary Purpose

Type 1 Diabetes Mellitus With Hypoglycemia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
ZT-01, 7 mg
ZT-01, 15 mg
ZT-01, 22 mg
Sponsored by
Zucara Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes Mellitus With Hypoglycemia focused on measuring nocturnal hypoglycemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has type 1 diabetes for at least 5 years Has history of recent nocturnal hypoglycemia (if using personal CGM, 4 events <54 mg/dL over previous 4 weeks at screening; if not using personal CGM then recent history of nocturnal symptomatic hypoglycemia at screening and 4 events 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: Currently uses automated insulin delivery system, eg closed loop or artificial pancreas 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

Sites / Locations

  • Metabolic Research InstituteRecruiting
  • Lucas Research Inc.Recruiting
  • Texas Diabetes & Endocrinology, PARecruiting
  • Endeavor Clinical Trials LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ZT-01 7 mg

ZT-01 15 mg

ZT-01 22 mg

Arm Description

Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order

Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order

Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order

Outcomes

Primary Outcome Measures

Incidence of nocturnal hypoglycemia
Rate of nocturnal (midnight to 06:00 AM) hypoglycemic events (glucose <54 mg/dL) lasting at least 15 minutes, compared to placebo

Secondary Outcome Measures

Incidence and severity of adverse events (AEs)
Number of patients experiencing AEs compared to placebo
Glucose time below range
Glucose time below 54 mg/dL (as %) compared to placebo
Incidence of hypoglycemia
Number of hypoglycemic events (glucose <70 mg/dL for at least 15 minutes, compared to placebo

Full Information

First Posted
February 27, 2023
Last Updated
September 27, 2023
Sponsor
Zucara Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05762107
Brief Title
A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
Acronym
ZONE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zucara Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Hypoglycemia
Keywords
nocturnal hypoglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
The participant will be randomized to receive placebo and one of three dose levels of ZT-01 in a crossover design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZT-01 7 mg
Arm Type
Experimental
Arm Description
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
Arm Title
ZT-01 15 mg
Arm Type
Experimental
Arm Description
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
Arm Title
ZT-01 22 mg
Arm Type
Experimental
Arm Description
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subject receives Placebo by subcutaneous injection daily for 28 days
Intervention Type
Drug
Intervention Name(s)
ZT-01, 7 mg
Intervention Description
Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days
Intervention Type
Drug
Intervention Name(s)
ZT-01, 15 mg
Intervention Description
Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days
Intervention Type
Drug
Intervention Name(s)
ZT-01, 22 mg
Intervention Description
Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days
Primary Outcome Measure Information:
Title
Incidence of nocturnal hypoglycemia
Description
Rate of nocturnal (midnight to 06:00 AM) hypoglycemic events (glucose <54 mg/dL) lasting at least 15 minutes, compared to placebo
Time Frame
During each 28 day treatment period
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs)
Description
Number of patients experiencing AEs compared to placebo
Time Frame
During each 28 day treatment period and 2-week followup
Title
Glucose time below range
Description
Glucose time below 54 mg/dL (as %) compared to placebo
Time Frame
During each 28 day treatment period
Title
Incidence of hypoglycemia
Description
Number of hypoglycemic events (glucose <70 mg/dL for at least 15 minutes, compared to placebo
Time Frame
During each 28 day treatment period
Other Pre-specified Outcome Measures:
Title
Glucose time in range
Description
Glucose time in range (70-180 mg/dL, %) compared to placebo
Time Frame
During each 28-day treatment period
Title
Mean glycemic variability
Description
Percent coefficient of variation of glucose values compared to placebo
Time Frame
During each 28 day treatment period
Title
Mean glucose concentration
Description
Mean glucose concentration compared to placebo
Time Frame
During each 28 day treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has type 1 diabetes for at least 5 years Has history of recent nocturnal hypoglycemia (if using personal CGM, 4 events <54 mg/dL over previous 4 weeks at screening; if not using personal CGM then recent history of nocturnal symptomatic hypoglycemia at screening and 4 events 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: Currently uses automated insulin delivery system, eg closed loop or artificial pancreas 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
Facility Information:
Facility Name
Metabolic Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alayzah Garcia, BS
Phone
516-802-3060
Ext
8032
Email
agarcia@metabolic-institute.com
First Name & Middle Initial & Last Name & Degree
Barry Horowitz, MD
Facility Name
Lucas Research Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari Dunn
Phone
252-222-5700
Ext
161
Email
mari.dunn@lucasresearch.com
First Name & Middle Initial & Last Name & Degree
Kathryn J Lucas, MD
Facility Name
Texas Diabetes & Endocrinology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory Fields
Phone
512-334-3505
Email
cfields@texasdiabetes.com
First Name & Middle Initial & Last Name & Degree
Jean Chen, MD
Facility Name
Endeavor Clinical Trials LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devin Ramirez-Escobedo
Phone
210-865-6045
Email
DRamirez-Escobedo@ergclinical.com
First Name & Middle Initial & Last Name & Degree
Emanuel P DeNoia, MD

12. IPD Sharing Statement

Learn more about this trial

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

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