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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZT-01 7 mg | Experimental | Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order |
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| ZT-01 15 mg | Experimental | Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order |
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| ZT-01 22 mg | Experimental | Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subject receives Placebo by subcutaneous injection daily for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | During each 28 day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Number of patients experiencing AEs compared to placebo | During each 28 day treatment period and 2-week followup |
| Glucose time below range | Glucose time below 54 mg/dL (as %) compared to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose time in range | Glucose time in range (70-180 mg/dL, %) compared to placebo | During each 28-day treatment period |
| Mean glycemic variability | Percent coefficient of variation of glucose values compared to placebo |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic | Recruiting | Birmingham | Alabama | 35233 | United States |
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The participant will be randomized to receive placebo and one of three dose levels of ZT-01 in a crossover design
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| ZT-01, 7 mg | Drug | Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days |
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| ZT-01, 15 mg | Drug | Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days |
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| ZT-01, 22 mg | Drug | Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days |
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| During each 28 day treatment period |
| Incidence of hypoglycemia | Number of hypoglycemic events (glucose <70 mg/dL for at least 15 minutes, compared to placebo | During each 28 day treatment period |
| During each 28 day treatment period |
| Mean glucose concentration | Mean glucose concentration compared to placebo | During each 28 day treatment period |
| Medical Investigations Indications Inc. | Recruiting | Little Rock | Arkansas | 72211 | United States |
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| Headlands Research | Recruiting | Escondido | California | 92025 | United States |
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| USC Keck Medicine Eastside Center for Diabetes | Recruiting | Los Angeles | California | 90022 | United States |
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| LCGK Research | Terminated | San Carlos | California | 94070 | United States |
| Barbara Davis Center for Diabetes | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale University - Diabetes Research Office | Recruiting | New Haven | Connecticut | 06511 | United States |
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| East Coast Institute for Research LLC | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Suncoast Clinical Research | Recruiting | New Port Richey | Florida | 34652 | United States |
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| Hanson Diabetes Center | Recruiting | Port Charlotte | Florida | 33952 | United States |
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| University of South Florida Diabetes & Endocrinology Clinic | Recruiting | Tampa | Florida | 33612 | United States |
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| Metabolic Research Institute | Recruiting | West Palm Beach | Florida | 33401 | United States |
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| Atlanta Diabetes Associates | Recruiting | Atlanta | Georgia | 21044 | United States |
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| Physicians Research Associates LLC | Recruiting | Lawrenceville | Georgia | 30046 | United States |
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| East Coast Institute for Research | Recruiting | Macon | Georgia | 31210 | United States |
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| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| IU Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
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| Baltimore VA Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| MedStar Good Samaritan Hospital | Recruiting | Baltimore | Maryland | 21239 | United States |
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| Elite Research Center | Recruiting | Flint | Michigan | 48532 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Palm Research Center, Inc. | Recruiting | Las Vegas | Nevada | 89148 | United States |
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| Albany Medical Center | Recruiting | Albany | New York | 12203 | United States |
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| NYC Research Inc. | Recruiting | Long Island City | New York | 11106 | United States |
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| NYU Langone Health CTSI | Recruiting | New York | New York | 10016 | United States |
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| Lucas Research Inc. | Recruiting | Morehead City | North Carolina | 28557 | United States |
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| Ohio State University Wexner Medical Center | Recruiting | Columbia | Ohio | 43210 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC Presbyterian Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| University Diabetes & Endocrine Consultants | Recruiting | Chattanooga | Tennessee | 37411 | United States |
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| Texas Diabetes & Endocrinology, PA | Recruiting | Austin | Texas | 78749 | United States |
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| North Texas Endocrine Center | Recruiting | Dallas | Texas | 75231 | United States |
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| Southern Endocrinology Associates | Recruiting | Mesquite | Texas | 75149 | United States |
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| Diabetes & Glandular Disease Clinic | Recruiting | San Antonio | Texas | 78229 | United States |
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| Diabetes & Endocrine Treatment Specialists | Recruiting | Sandy City | Utah | 84093 | United States |
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| University of Washington Diabetes Institute - Clinical Research Unit | Recruiting | Seattle | Washington | 98109 | United States |
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| Centricity Research Calgary Endocrinology | Recruiting | Calgary | Alberta | T2H 2G4 | Canada |
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| Richmond Road Diagnostic & Treatment Centre, Clinical Trials Unit | Recruiting | Calgary | Alberta | T2T5C7 | Canada |
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| BC Diabetes | Recruiting | Vancouver | British Columbia | V5Y 3W2 | Canada |
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| Centricity Research Barrie Endocrinology | Withdrawn | Barrie | Ontario | L4N 7L3 | Canada |
| Centricity Research Vaughan Endocrinology | Recruiting | Concord | Ontario | L4K 4M2 | Canada |
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| Centricity Research Etobicoke Endocrinology | Recruiting | Etobicoke | Ontario | M9R 4E1 | Canada |
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| Centricity Research Toronto | Recruiting | Toronto | Ontario | M4G 3E8 | Canada |
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| Mount Sinai Hospital: Leadership Sinai Centre for Diabetes | Recruiting | Toronto | Ontario | M5T 3L9 | Canada |
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