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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00854035
First received: February 27, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

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 ]

Enrollment: 266
Study Start Date: February 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E 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
Placebo Comparator: P 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

Locations
Japan
Chubu Region
Chubu, Japan
Chugoku Region
Chugoku, Japan
Hokuriku Region
Hokuriku, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Kyushu Region
Kyushu, Japan
Tohoku Region
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Chair: Seki Akiteru First Division Clinical Development Planning I
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00854035     History of Changes
Other Study ID Numbers: ONO-5435-15
Study First Received: February 27, 2009
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
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 May 16, 2013