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

Sponsor:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00363519

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 glimepiride as monotherapy

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride Add-on Study for Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

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:	195
Study Start Date:	August 2006
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

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

Criteria

Inclusion Criteria:

Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion Criteria:

Patients with Type 1 diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363519

Locations

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

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Mikio Nishii

Ono Pharma

More Information

No publications provided

Responsible Party:	Hiroshi Awata, Executive Director, Development Headquarters, Development Headquarters, ONO Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00363519 History of Changes
Other Study ID Numbers:	ONO-5435-09
Study First Received:	August 11, 2006
Last Updated:	February 27, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

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
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 February 09, 2012