Effect of ZT-01 on Frequency of Nocturnal Hypoglycemia in Type 1 Diabetes Mellitus

STUDY BASICS

Have you been diagnosed with type 1 diabetes for at least 5 years? You may be eligible for a research study to assess the effect, safety and tolerability of an experimental study drug. This study will involve about 6 study visits and 2 phone calls and will take approximately 16 weeks to complete. Compensation is provided.

STUDY PURPOSE

Low blood sugar (hypoglycemia) is a common complication in insulin-dependent diabetes or type 1 diabetes mellitus (T1DM). During hypoglycemic conditions, not enough glucagon (a hormone that controls blood sugar) is produced in people with T1DM.

The study drug ZT-01 is designed to inhibit somatostatin, a hormone that inhibits the glucagon response to hypoglycemia. Thus, ZT-01 may be able to restore glucagon production to prevent hypoglycemia, which could improve both health and quality of life in people with T1DM.

The purposes of this study are:

• To assess the effect of ZT-01 days on incidence of night time (nocturnal) hypoglycemia in participants with T1DM;
• To assess the safety and tolerability of study drug ZT-01;
• To look for study drug’s safety indicators (called safety biomarkers);
• To understand how the study drug is changed by and removed from the body (called pharmacokinetic or PK testing);
• To understand how the study drug is affecting the body (called PD testing).

COULD THIS STUDY BE RIGHT FOR YOU?

• Are 18-75 years old
• Have been diagnosed with type 1 diabetes for at least 5 years
• Use insulin
• Have a BMI between 18.5 and 33

WHAT PARTICIPANTS CAN EXPECT

The study consists of a

• Screening Period (4 or 8 weeks): During this time, participants will be evaluated to see if they qualify to join the study.
• Study Treatment Period 1 (4 weeks): Participants will be randomly assigned to receive either the study drug or a placebo (an inactive injection that looks like the study drug but has no effect).
• Washout Period 1 (about 14 days): Participants will stop taking any study medication to allow the drug to completely leave their system.
• Study Treatment Period 2 (4 weeks): Participants who initially received the study drug will now receive the placebo, and those who initially received the placebo will now receive the study drug.
• Washout Period 2 (about 14 days): Again, participants will stop taking any study medication to ensure the drug is fully cleared from their body.
• Final Study Visit: Participants will return to the study site for a final check-up and assessment.