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

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.
ClinicalTrials.gov Identifier: NCT00363948
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 metformin as monotherapy

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo Drug: Sitagliptin phosphate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus
Study Start Date : August 2006
Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: P 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
Experimental: E 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


Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
  2. safety [ Time Frame: 52 weeks ]
  3. tolerability [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Plasma glucose [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363948


Locations
Japan
Chubu Region
Chubu, Japan
Chugoku Region
Chugoku, Japan
Hokkaido Region
Hokkaido, Japan
Hokuriku Region
Hokuriku, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Kyushu Region
Kyushu, Japan
Tohoku Region
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Mikio Nishii Ono Pharmaceutical Co. Ltd
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00363948     History of Changes
Other Study ID Numbers: ONO-5435-08
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
MK-0431
ONO-5435
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action