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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00363519
First received: August 11, 2006
Last updated: June 12, 2012
Last verified: June 2012

August 11, 2006
June 12, 2012
August 2006
January 2008   (final data collection date for primary outcome measure)
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • tolerability [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c
  • safety
  • tolerability
Complete list of historical versions of study NCT00363519 on ClinicalTrials.gov Archive Site
Plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Plasma glucose
Not Provided
Not Provided
 
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Placebo Comparator: P
    Intervention: Drug: Placebo
  • Experimental: E
    Intervention: Drug: Sitagliptin phosphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
Not Provided
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with Type 1 diabetes mellitus
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00363519
ONO-5435-09
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Mikio Nishii Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP