Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Verified by: Ono Pharma, February 2009
First Received: August 11, 2006 | Last Updated: February 27, 2009 | Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 195
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The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as...

Brief Summary

Official Title: “MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride Add-on Study for Patients With Type 2 Diabetes Mellitus”

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

  • Drug: Placebo
    • Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
  • Drug: Sitagliptin phosphate
    • Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: P
  • Experimental: E

Outcome Measures for this Clinical Trial

Primary Measures

  • HbA1c
    • Time Frame: 12 weeks
      Safety Issue?: No
  • safety
    • Time Frame: 52 weeks
      Safety Issue?: Yes
  • tolerability
    • Time Frame: 52 weeks
      Safety Issue?: Yes

Secondary Measures

  • Plasma glucose
    • Time Frame: 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion Criteria:

  • Patients with Type 1 diabetes mellitus

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Ono Pharma Industry

Overall Clinical Trial Officials and Contacts

Mikio Nishii Study Director Ono Pharma  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00363519

Study ID Number: ONO-5435-09

ClinicalTrials.gov Identifier: NCT00363519

Health Authority: Japan: Ministry of Health, Labor and Welfare

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