16 September 2026 editorial review · Trial
CIT-07: donor-islet transplantation for severe hypoglycemia: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Corrected product identity: CIT-07 has 48 participants and is distinct from Lantidra’s UIH 001/UIH 002 registration studies totaling 30. Primary CIT-07 abstract and FDA regulatory review support the distinction, outcomes and major harms.
Registry: NCT00434811; COMPLETED; updated 2019-07-17; enrollment 48 (ACTUAL); results not posted.
Endpoint comparison: Proportion of participants with a HbA1c less than 7.0% AND free of severe hypoglycemic events (From Day 28 to Day 365 (inclusive) following the first islet transplant, with the day of transplant designated Day 0).
Sources for this record: Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia (peer-reviewed); FDA Summary Basis for Regulatory Action: Lantidra (regulatory); NCT00434811: study record (registry).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.