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Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Jun 3, 2012, no change to tracked fieldsv6-v7
  2. Notable Primary endpoints revised (4) Secondary endpoint revisedv5 Show 1 more changeShow less
  3. Notable Results first posted: Aug 11, 2011 Primary endpoints: 1 to 4 · Secondary endpoints: 2 to 1v4 Show 2 more changesShow less
    • Primary endpoints: 1 to 4
    • Secondary endpoints: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study Status, Referencesv3
  5. Minor Trial status: Recruiting to Completed Enrollment target: estimated 160 to confirmed 183 · Study sites: 1 to 0 · Completion date: Sep 2007 · 3 morev2 Show 6 more changesShow less
    • Enrollment target: estimated 160 to confirmed 183
    • Study sites: 1 to 0
    • Completion date: Sep 2007
    • Interventions: MCI-196 (Colestimide(JAN), Colestilan(INN), CHOLEBINE®) (Drug) to MCI-196 (Drug), Placebo of MCI-196 Tablet (Drug)
    • Secondary endpoints: 1 to 2
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.
Trial Details
NCT Number NCT00497198
Lead Sponsor Tanabe Pharma Corporation
Conditions Type 2 Diabetes
Enrollment 183 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov