A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
- Conditions
- Type 1 Diabetes Mellitus with Hypoglycemia
- Interventions
- Drug: PlaceboDrug: ZT-01, 7 mgDrug: ZT-01, 22 mgDrug: ZT-01, 15 mg
- Registration Number
- NCT05762107
- Lead Sponsor
- Zucara Therapeutics Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 186
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ZT-01 7 mg Placebo Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order ZT-01 7 mg ZT-01, 7 mg Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order ZT-01 22 mg ZT-01, 22 mg Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order ZT-01 15 mg Placebo Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order ZT-01 15 mg ZT-01, 15 mg Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order ZT-01 22 mg Placebo Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
- Primary Outcome Measures
Name Time Method Incidence of nocturnal hypoglycemia During each 28 day treatment period 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
Name Time Method Incidence and severity of adverse events (AEs) During each 28 day treatment period and 2-week followup Number of patients experiencing AEs compared to placebo
Incidence of hypoglycemia During each 28 day treatment period Number of hypoglycemic events (glucose \<70 mg/dL for at least 15 minutes, compared to placebo
Glucose time below range During each 28 day treatment period Glucose time below 54 mg/dL (as %) compared to placebo
Trial Locations
- Locations (25)
Headlands Research
🇺🇸Escondido, California, United States
USC Keck Medicine Eastside Center for Diabetes
🇺🇸Los Angeles, California, United States
LCGK Research
🇺🇸San Carlos, California, United States
East Coast Institute for Research LLC
🇺🇸Jacksonville, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Hanson Diabetes Center
🇺🇸Port Charlotte, Florida, United States
Metabolic Research Institute
🇺🇸West Palm Beach, Florida, United States
East Coast Institute for Research
🇺🇸Macon, Georgia, United States
IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
MedStar Good Samaritan Hospital
🇺🇸Baltimore, Maryland, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Lucas Research Inc.
🇺🇸Morehead City, North Carolina, United States
University Diabetes & Endocrine Consultants
🇺🇸Chattanooga, Tennessee, United States
Texas Diabetes & Endocrinology, PA
🇺🇸Austin, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Diabetes & Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Centricity Research Calgary Endocrinology
🇨🇦Calgary, Alberta, Canada
BC Diabetes
🇨🇦Vancouver, British Columbia, Canada
Centricity Research Barrie Endocrinology
🇨🇦Barrie, Ontario, Canada
Centricity Research Vaughan Endocrinology
🇨🇦Concord, Ontario, Canada
Centricity Research Etobicoke Endocrinology
🇨🇦Etobicoke, Ontario, Canada
Centricity Research Toronto
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital: Leadership Sinai Centre for Diabetes
🇨🇦Toronto, Ontario, Canada