A Phase 1 interventional study of ZT-01 low dose and ZT-01 high dose in Type 1 Diabetes and Hypoglycemia, sponsored by Zucara Therapeutics Inc.. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Zucara Therapeutics Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia.
Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp.
Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Zucara Therapeutics Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Subjects will receive a single administration of each treatment in this order during three consecutive clamps
Drug: ZT-01 low dose · Drug: ZT-01 high dose · Drug: Placebo
Single subcutaneous (SC) injection of ZT-01 3 mg during hypoglycemic clamp
Single SC injection of ZT-01 20 mg during hypoglycemic clamp
Single SC injection of placebo during hypoglycemic clamp
Change in glucagon between euglycemia and hypoglycemia
Mean and peak glucagon level during euglycemia and each hypoglycemic period of the clamp
Time frame: During each clamp, up to 12 weeks
Insulin infused
Insulin administered during euglycemia and each hypoglycemic period of the clamp
Time frame: During each clamp, up to 12 weeks
Insulin infusion rate
Rate of insulin administered during euglycemia and each hypoglycemic period of the clamp
Time frame: 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
Time frame: During each clamp, up to 12 weeks
Change in growth hormone between euglycemia and hypoglycemia
Growth hormone during euglycemia and each stable hypoglycemic period
Time frame: During each clamp, up to 12 weeks
Change in cortisol between euglycemia and hypoglycemia
Cortisol during euglycemia and each stable hypoglycemic period
Time frame: During each clamp, up to 12 weeks
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.
Time frame: During each clamp, up to 12 weeks
Plan to share: No
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This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Zucara Therapeutics Inc.