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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. 2 versions Re-verified since Jun 3, 2012, no change to tracked fieldsv6-v7
  2. Primary endpoints revised (4)
    • Secondary endpoint revised
    v5
  3. Results first posted: Aug 11, 2011
    • Primary endpoints: 1 to 4
    • Secondary endpoints: 2 to 1
    v4
  4. Study Status, Referencesv3
  5. Trial status: Recruiting to Completedv2 Show 6 more changesShow less
    • Enrollment target: estimated 160 to confirmed 183
    • Study sites: 1 to 0
    • Study 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
  6. Study First Submitted
  • 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
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 183 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov