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

Phase 3

Completed

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

• Registration Number: NCT00363844
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

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: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• Patients with type 2 diabetes mellitus on diet and exercise therapy

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Exclusion Criteria

• Patients with type 1 diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E	Sitagliptin phosphate	-

Primary Outcome Measures

Name	Time	Method
safety	52 weeks
tolerability	52 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c	52 weeks
Plasma glucose	52 weeks

Trial Locations

Locations (8)

Kanto Region; 🇯🇵 Kanto, Japan

Chubu Region; 🇯🇵 Chubu, Japan

Hokkaido Region; 🇯🇵 Hokkaido, Japan

Chugoku Region; 🇯🇵 Chugoku, Japan

Kinki Region; 🇯🇵 Kinki, Japan

Shikoku Region; 🇯🇵 Shikoku, Japan

Kyushu Region; 🇯🇵 Kyushu, Japan

Tohoku Region; 🇯🇵 Tohoku, Japan