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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363519
First Posted: August 15, 2006
Last Update Posted: June 14, 2012
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.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  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 3

Study Type: Interventional
Study Design: 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 - Glimepiride add-on Study for Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ]
  • safety [ Time Frame: 52 weeks ]
  • tolerability [ Time Frame: 52 weeks ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (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 glimepiride 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): 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 Pharmaceutical Co. Ltd
Investigators
Study Director: Mikio Nishii Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00363519     History of Changes
Other Study ID Numbers: ONO-5435-09
First Submitted: August 11, 2006
First Posted: August 15, 2006
Last Update Posted: June 14, 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