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

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00363948

Purpose

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Placebo Drug: Sitagliptin phosphate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	188
Study Start Date:	August 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator	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
E: Experimental	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

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363948

Locations

Japan
Hokkaido Region
Hokkaido, Japan
Tohoku Region
Tohoku, Japan
Kanto Region
Kanto, Japan
Hokuriku Region
Hokuriku, Japan
Kyushu Region
Kyushu, Japan
Kinki Region
Kinki, Japan
Chugoku Region
Chugoku, Japan
Chubu Region
Chubu, Japan

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Mikio Nishii

Ono Pharma

More Information

No publications provided

Responsible Party:	Development Headquarters, ONO Pharmaceutical Co., Ltd ( Hiroshi Awata, Executive Director, Development Headquarters )
Study ID Numbers:	ONO-5435-08
Study First Received:	August 11, 2006
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00363948 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

MK-0431
ONO-5435
Type 2 diabetes mellitus

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on September 02, 2009