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NCT00363948 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00363948
Other study ID # ONO-5435-08
Secondary ID
Status Completed
Phase Phase 3
First received August 11, 2006
Last updated June 12, 2012
Start date August 2006

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

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 metformin as monotherapy

Recruitment information / eligibility
Status Completed
Enrollment 188
Est. completion date
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria:

- Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

Exclusion Criteria:

- Patients with type 1 diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Japan Chubu Region Chubu
Japan Chugoku Region Chugoku
Japan Hokkaido Region Hokkaido
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 12 weeks No
Primary safety 52 weeks Yes
Primary tolerability 52 weeks Yes
Secondary Plasma glucose 12 weeks No
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