Tests E-islet 01 in adults with type 1 diabetes and severe low blood sugar
Tests E-islet 01 in adults with type 1 diabetes and low blood sugar awareness.
Plain-language title generated from the registry record
Registry title: A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07126873, who can take part
Where in China
- Shanghai Changzheng HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EndoCell Therapeutics, Inc.
- Trial code
- NCT07126873
- Record updated
- 22 August 2025
- Original description
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 hypoglycemiaRead full original descriptionShow less
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
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
Inclusion: 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:; At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment; Unaware hypoglycemia evaluated using the Clarke scoring system; Willing and able to conduct self-blood glucose monitoring as required, with good compliance; Voluntarily participate and sign the informed consent form.
Exclusion: Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment; Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); History of malignancy within the past 5 years or undergoing antitumor treatment; Other situations judged by the investigator as unsuitable for participation in the trial.