MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00854035

Purpose

This Phase III clinical trial will examine the efficacy, safety, and tolerability 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 insulin monotherapy.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK-0431/ONO-5435	Phase III

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness

Drug Information available for: Insulin Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: 16 weeks and 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

2 hour post-meal glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Fasting plasma glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	232
Study Start Date:	February 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
E: Experimental	Drug: MK-0431/ONO-5435 Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD
P: Placebo Comparator	Drug: MK-0431/ONO-5435 Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 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:

Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy

Exclusion Criteria:

Patients with Type 1 Diabetes Mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854035

Contacts

Contact: Morimoto Kinya

km.morimoto@ono.co.jp

Locations

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

Sponsors and Collaborators

Ono Pharma

Investigators

Study Chair:

Kawashima Masaru

First Division Clinical Development Planning I

More Information

No publications provided

Responsible Party:	Development Headquarters, Ono Pharmaceutical Co., Ltd ( Hiroshi Awata, Executive Director, Development Headquarters )
Study ID Numbers:	ONO-5435-15
Study First Received:	February 27, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00854035 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
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Glucose Metabolism Disorders
Metabolic Disorder
Insulin
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 May 06, 2009