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MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517321
First Posted: January 25, 2012
Last Update Posted: July 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MSD K.K.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
November 2, 2011
January 25, 2012
July 9, 2013
Not Provided
Not Provided
Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability [ Time Frame: 12 weeks and 52 weeks ]
Same as current
Complete list of historical versions of study NCT01517321 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: 12 weeks ]
  • 2-hour postmeal glucose [ Time Frame: 12 weeks ]
  • Fasting plasma glucose [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: MK-0431/ONO-5435
    Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
  • Drug: Placebo, MK-0431/ONO-5435
    Double-blind period (12 wks); 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 to 100 mg QD.
  • Experimental: E
    Intervention: Drug: MK-0431/ONO-5435
  • Placebo Comparator: P
    Intervention: Drug: Placebo, MK-0431/ONO-5435
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Not Provided
Not Provided

Inclusion Criteria:

  • Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01517321
ONO-5435-17
Japic CTI-111668 ( Registry Identifier: Japan Pharmaceutical Information Center )
Not Provided
Not Provided
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
MSD K.K.
Study Chair: Akiteru Seki First Division Clinical Development Planning 1
Ono Pharmaceutical Co. Ltd
July 2013

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