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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Sitagliptin phosphate

• Registration Number: NCT00363948
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Primary Completion: 2008-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Placebo	-
E	Sitagliptin phosphate	-

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks
safety	52 weeks
tolerability	52 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma glucose	12 weeks

Trial Locations

Locations (8)

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, Japan