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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 is ongoing, but not recruiting participants.
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: December 28, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: MK-0431/ONO-5435
Drug: Placebo, MK-0431/ONO-5435
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Arms Assigned Interventions
Experimental: E 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.
Placebo Comparator: P 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517321

Locations
Japan
Chubu Region Clinical Site
Chubu, Japan
Chugoku Region Clinical Site
Chugoku, Japan
Kanto Region Clinical Site
Kanto, Japan
Kinki Region Clinical Site
Kinki, Japan
Kyusyu Region Clinical Site
Kyusyu, Japan
Tohoku Region Clinical Site
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
MSD K.K.
Investigators
Study Chair: Akiteru Seki First Division Clinical Development Planning 1
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01517321     History of Changes
Other Study ID Numbers: ONO-5435-17, Japic CTI-111668
Study First Received: November 2, 2011
Last Updated: December 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013