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Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 25, 2022 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2023 to Dec 2025 Start date: Oct 2021 to May 2022 · Completion date: Jul 2025 to Dec 2026 · Secondary endpoints: details revised at 2 of 7 entries · 3 morev4 Show 6 more changesShow less
    • Start date: Oct 2021 to May 2022
    • Completion date: Jul 2025 to Dec 2026
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description shortened, about 7 words
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Withdrawn to Not Yet Recruiting Primary endpoint revised · Enrollment target: 0 to 240 · Start date: Dec 2021 to Oct 2021 · 7 morev3 Show 10 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 0 to 240
    • Start date: Dec 2021 to Oct 2021
    • Interventions: Berberine hydrochloride and stachyose combination (Drug), Insulin (Drug), Placebo (Drug) to Berberine (Drug), Berberine placebo tablets (Drug), Inulin (Drug), Inulin placebo tablets (Drug)
    • Secondary endpoints revised (7)
    • Study description expanded, about 24 words
    • Site contact updated
    • Study title revised
    • Study arms: 2 to 4
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: recruitment difficulties Enrollment target: estimated 60 to confirmed 0 · Primary completion date: Dec 2022 to Dec 2023 · Start date: Jan 2021 to Dec 2021 · 4 morev2 Show 7 more changesShow less
    • Enrollment target: estimated 60 to confirmed 0
    • Primary completion date: Dec 2022 to Dec 2023
    • Start date: Jan 2021 to Dec 2021
    • Completion date: Dec 2023 to Jul 2025
    • Study description shortened, about 53 words
    • Site contact updated
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.
Trial Details
NCT Number NCT04698330
Lead Sponsor Second Xiangya Hospital of Central South University
Conditions Type 1 Diabetes Mellitus, Autoimmune Diabetes
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov