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MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517321
First Posted: January 25, 2012
Last Update Posted: July 9, 2013
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.
Collaborator:
MSD K.K.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  Purpose
This Phase III clinical trial will examine the safety, tolerability, and efficacy 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 rapid-acting insulin secretagogue monotherapy.

Condition Intervention Phase
Type 2 Diabetes Drug: MK-0431/ONO-5435 Drug: Placebo, MK-0431/ONO-5435 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability [ Time Frame: 12 weeks and 52 weeks ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ]
  • 2-hour postmeal glucose [ Time Frame: 12 weeks ]
  • Fasting plasma glucose [ Time Frame: 12 weeks ]

Arms Assigned Interventions
Experimental: E Drug: MK-0431/ONO-5435
Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
Placebo Comparator: P Drug: Placebo, MK-0431/ONO-5435
Double-blind period (12 wks); 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 to 100 mg QD.

  Eligibility

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:

  • Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue 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): NCT01517321


Locations
Japan
Chubu Region Clinical Site
Chubu, Japan
Chugoku Region Clinical Site
Chugoku, Japan
Kanto Region Clinical Site
Kanto, Japan
Kinki Region Clinical Site
Kinki, Japan
Kyusyu Region Clinical Site
Kyusyu, Japan
Tohoku Region Clinical Site
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
MSD K.K.
Investigators
Study Chair: Akiteru Seki First Division Clinical Development Planning 1
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01517321     History of Changes
Other Study ID Numbers: ONO-5435-17
Japic CTI-111668 ( Registry Identifier: Japan Pharmaceutical Information Center )
First Submitted: November 2, 2011
First Posted: January 25, 2012
Last Update Posted: July 9, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Insulin, Short-Acting
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