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To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion date: Jun 30, 2025 to Dec 31, 2025v7
  2. Minor Primary completion date changed from estimate of Jan 31, 2025 to Jan 17, 2025v6
  3. Minor Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 31, 2024 to Jan 31, 2025 · Site details revisedv5 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2024 to Jan 31, 2025
    • Site details revised
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Primary endpoint revised Primary completion date: Dec 2024 to Dec 31, 2024 · Completion date: Jun 2025 to Jun 30, 2025 · Secondary endpoints expanded, about 65 wordsv3 Show 3 more changesShow less
    • Primary completion date: Dec 2024 to Dec 31, 2024
    • Completion date: Jun 2025 to Jun 30, 2025
    • Secondary endpoints expanded, about 65 words

    See this version in full on ClinicalTrials.gov ↗

  6. Notable Trial status: Not Yet Recruiting to Recruiting Enrollment target: 10000 to 15000 · Study sites: 0 to 1 · Start date changed from estimate of Jul 2023 to Sep 21, 2023 · 4 morev2 Show 7 more changesShow less
    • Enrollment target: 10000 to 15000
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Sep 21, 2023
    • Interventions: Enavogliflozin (Drug) to Enavogliflozin (Drug), Enavogliflozin (Drug)
    • Study description expanded, about 12 words
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet or Envlomet SR Tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.
Trial Details
NCT Number NCT05926414
Lead Sponsor Daewoong Pharmaceutical Co. LTD.
Conditions Diabetes Mellitus, Type 2
Enrollment 15,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov