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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854035
• Other study ID #: ONO-5435-15
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2009
• Last updated: June 12, 2012
• Start date: February 2009

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		16 weeks	No
Primary	Safety and Tolerability		16 weeks and 52 weeks	Yes
Secondary	2 hour post-meal glucose		16 weeks	No
Secondary	Fasting plasma glucose		16 weeks	No