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Clinical Trial Details

Trial ID: L7125
Source ID: NCT05007977
Associated Drug: Zt-01 Low Dose
Title: Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: ZT-01 low dose|DRUG: ZT-01 high dose|DRUG: Placebo
Outcome Measures: Primary: Change in glucagon between euglycemia and hypoglycemia, Mean and peak glucagon level during euglycemia and each hypoglycemic period of the clamp, During each clamp, up to 12 weeks | Secondary: Insulin infused, Insulin administered during euglycemia and each hypoglycemic period of the clamp, During each clamp, up to 12 weeks|Insulin infusion rate, Rate of insulin administered during euglycemia and each hypoglycemic period of the clamp, During each clamp, up to 12 weeks|Change in catecholamines between euglycemia and hypoglycemia, Epinephrine and norepinephrine during euglycemia and each stable hypoglycemic period of the clamp, During each clamp, up to 12 weeks|Change in growth hormone between euglycemia and hypoglycemia, Growth hormone during euglycemia and each stable hypoglycemic period, During each clamp, up to 12 weeks|Change in cortisol between euglycemia and hypoglycemia, Cortisol during euglycemia and each stable hypoglycemic period, During each clamp, up to 12 weeks | Other: Symptom score during hypoglycemia, The Edinburgh hypoglycemia symptom score assesses the presence and extent (on a scale of 1, not present to 7, present a great deal) of 16 common symptoms which may be experienced by an individual while their blood glucose is low. The score does not indicate any outcome., During each clamp, up to 12 weeks
Sponsor/Collaborators: Sponsor: Zucara Therapeutics Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-08
Completion Date: 2022-04-18
Results First Posted:
Last Update Posted: 2023-07-12
Locations: LMC Manna Research, Toronto, Ontario, M4G 3E8, Canada
URL: https://clinicaltrials.gov/show/NCT05007977