A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes (ZONE)
Type 1 Diabetes Mellitus With Hypoglycemia
About this trial
This is an interventional prevention trial for Type 1 Diabetes Mellitus With Hypoglycemia focused on measuring nocturnal hypoglycemia
Eligibility Criteria
Inclusion Criteria: Has type 1 diabetes for at least 5 years Has history of recent nocturnal hypoglycemia (if using personal CGM, 4 events <54 mg/dL over previous 4 weeks at screening; if not using personal CGM then recent history of nocturnal symptomatic hypoglycemia at screening and 4 events 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: Currently uses automated insulin delivery system, eg closed loop or artificial pancreas 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
Sites / Locations
- Metabolic Research InstituteRecruiting
- Lucas Research Inc.Recruiting
- Texas Diabetes & Endocrinology, PARecruiting
- Endeavor Clinical Trials LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
ZT-01 7 mg
ZT-01 15 mg
ZT-01 22 mg
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order