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New treatment option for Type 1 Diabetes Mellitus With Hypoglycemia
Official title A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05762107
What this study is testing
What is ZT-01, 7 mg?
ZT-01, 7 mg is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for type 1 diabetes mellitus with hypoglycemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- HbA1c at screening \</= 10.0%
- Body mass index (BMI) at screening \>/=18.5 to \<33 kg/m2
You likely can't join if
- 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...
- Clinically significant kidney disease
- Abnormal liver function
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Los Angeles, California, United States
- San Carlos, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- New Port Richey, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Lawrenceville, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
+ 23 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Escondido, California, United States; Los Angeles, California, United States; San Carlos, California, United States; Aurora, Colorado, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.