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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:
Collaborator:
MSD K.K.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01517321
First received: November 2, 2011
Last updated: July 7, 2013
Last verified: July 2013

November 2, 2011
July 7, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01517321 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 2-hour postmeal glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 Blind (Subject, 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
Not Provided
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01517321
ONO-5435-17, Japic CTI-111668
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