A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Recruiting
Phase 1
Phase 2
Interventional Study
Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Severe Hypoglycemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 21 (estimated)
- Sponsor
- EndoCell Therapeutics, Inc. · Other
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About This Trial
This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Clinical history of Type 1 Diabetes with \> 5 years of duration
* 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test
* Under continuous insulin therapy, Participants have at least one of the following conditions:
1. At least one episode of documented sev…
Contacts