Condition: Type 1 Diabetes Mellitus With Hypoglycemia · Sponsor: Zucara Therapeutics Inc.
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 requireme…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic | Birmingham, Alabama, United States | Recruiting |
| Medical Investigations Indications Inc. | Little Rock, Arkansas, United States | Recruiting |
| Headlands Research | Escondido, California, United States | Recruiting |
| USC Keck Medicine Eastside Center for Diabetes | Los Angeles, California, United States | Recruiting |
| LCGK Research | San Carlos, California, United States | Terminated |
| Barbara Davis Center for Diabetes | Aurora, Colorado, United States | Recruiting |
| Yale University - Diabetes Research Office | New Haven, Connecticut, United States | Recruiting |
| East Coast Institute for Research LLC | Jacksonville, Florida, United States | Recruiting |
| Suncoast Clinical Research | New Port Richey, Florida, United States | Recruiting |
| Hanson Diabetes Center | Port Charlotte, Florida, United States | Recruiting |
| University of South Florida Diabetes & Endocrinology Clinic | Tampa, Florida, United States | Recruiting |
| Metabolic Research Institute | West Palm Beach, Florida, United States | Recruiting |
+ 34 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05762107