Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ono Pharma |
---|---|
Information provided by: | Ono Pharma |
ClinicalTrials.gov Identifier: | NCT00854035 |
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 |
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 |
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
|
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Morimoto Kinya | km.morimoto@ono.co.jp |
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 |
Study Chair: | Kawashima Masaru | First Division Clinical Development Planning I |
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: | June 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00854035 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
MK-0431/ONO-5435 Type 2 diabetes mellitus |
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 |
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 |