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

Launched by ZUCARA THERAPEUTICS INC. · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called ZT-01 to see if it can help prevent low blood sugar episodes (called hypoglycemia) that happen at night in adults with type 1 diabetes. The trial aims to find out if ZT-01 can reduce the number of these nighttime low blood sugar events and how it affects overall blood sugar levels. Participants will self-inject the drug or a placebo (an inactive treatment) before bedtime during two separate 4-week periods. Throughout the study, they will wear a continuous glucose monitor (CGM) to track their blood sugar levels and keep a diary of their daily experiences.

To be eligible for the study, participants must be at least 18 years old, have had type 1 diabetes for at least five years, and have a history of nighttime low blood sugar episodes. They should not have experienced any severe low blood sugar that required assistance in the past month. Participants will have about 16 weeks of involvement, which includes several visits to the study site for health checks and tests, such as blood samples and monitoring of their heart. This study could provide valuable insights into managing nighttime low blood sugar in people with type 1 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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