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Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Study acronym: TOLEDDO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Eligibility criteria expanded, about 37 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 37 words
  2. Primary and study completion dates: Aug 2026 to Aug 2028v9
  3. Re-verified, no change to tracked fieldsv8
  4. Trial status: Active, Not Recruiting to Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Aug 2024 to Aug 2026v5
  2. Primary completion date: Aug 2022 to Aug 2024 Eligibility criteria expanded, about 29 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2022 to Jul 12, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2022 to Jul 12, 2022
    • Site details revised
  4. Start date: Mar 2022 to Jul 2022 Primary completion date: Apr 2022 to Aug 2022 · Completion date: Apr 2024 to Aug 2024v2 Show 2 more changesShow less
    • Primary completion date: Apr 2022 to Aug 2022
    • Completion date: Apr 2024 to Aug 2024
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Between 16% and 22% of type 1 diabetic patients present a clinical and biological profile of insulin resistance favored by a family history of type 2 diabetes or metabolic syndrome. They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes. For several years, GLP1 agonists have been successfully used in the treatment of type 2 diabetes, leading to very significant improvements in glycemic control and weight loss. Because of the insulin-sensitizing power of GLP1 agonists, the investigators hypothesize that they could reduce insulin resistance in patients with "double diabetes" and thus improve their glycemic control. The investigators propose to use in this study semaglutide, the most recent and most potent GLP1 agonist (superiority demonstrated compared to exenatide LP and dulaglutide) and administered as a weekly subcutaneous injection (in contrast to liraglutide administered daily).
Trial Details
NCT Number NCT05305794
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Double Diabetes
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov