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

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ClinicalTrials.gov Identifier: NCT00363844
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin phosphate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MK-0431/ONO-5435 Phase III Clinical Study - Long-term Treatment Study for Patients With Type 2 Diabetes Mellitus
Study Start Date : August 2006
Actual Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: E Drug: Sitagliptin phosphate
50 mg QD or 100 mg QD for 12 months



Primary Outcome Measures :
  1. safety [ Time Frame: 52 weeks ]
  2. tolerability [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 52 weeks ]
  2. Plasma glucose [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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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 and exercise therapy

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus

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): NCT00363844


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

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00363844     History of Changes
Other Study ID Numbers: ONO-5435-10
First Posted: August 15, 2006    Key Record Dates
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