ZT-01 for Night-time Low Blood Sugar in Type 1 Diabetes
This study is looking at how ZT-01 affects low blood sugar (hypoglycemia) at night in adults with type 1 diabetes. ZT-01 is thought to work by increasing a hormone called glucagon during low blood sugar, which might help prevent these episodes. We want to see if ZT-01, given as a daily injection, can reduce the number of night-time low blood sugar events and what its effects are on overall blood sugar levels. We will also be checking the safety of ZT-01. You might be able to join if you are 18-75 years old, have had type 1 diabetes for at least 5 years, and experience night-time low blood sugar.
- Study design
- This interventional study plans to enroll 186 participants. Participants will receive either ZT-01 at different doses (7 mg, 15 mg, or 22 mg) or a placebo (an inactive substance) by daily subcutaneous injection.
- What's involved
- Participants will wear a continuous glucose monitor (CGM) provided by the study during two 4-week periods. During these periods, they will self-inject the study drug before bed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, incidence of nocturnal hypoglycemia, will be measured during each 28-day treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
At a glance
Conditions
Where it's being run
46 sites across 26 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of nocturnal hypoglycemiaDuring each 28 day treatment period
Rate of nocturnal (midnight to 06:00 AM) hypoglycemic events (glucose \<54 mg/dL) lasting at least 15 minutes, compared to placebo