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Effect of C-peptide on Hypoglycemic Counterregulation

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 1 entryv7
  2. Primary endpoints: 3 to 1 Secondary endpoints: 4 to 2v6 Show 1 more changeShow less
    • Secondary endpoints: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Enrolling by Invitation to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Active, Not Recruiting to Enrolling by Invitationv3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Iatrogenic hypoglycemia is the most prominent barrier to the safe, effective management of blood sugar in people with type 1 diabetes due to periodic over-insulinization. During insulin-induced hypoglycemia, glucagon secretion is diminished in type 1 diabetes which, in turn, reduces hepatic glucose production and increases the depth and duration of hypoglycemic episodes. We have observed that the naturally occurring protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia, which increases hepatic glucose production; the experiments in this application will shed light on the translation of this finding to the human.
Trial Details
NCT Number NCT06470295
Lead Sponsor University of Cincinnati
Conditions Hypoglycemia, Type 1 Diabetes
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov