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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK-0431/ONO-5435; Drug: Placebo, MK-0431/ONO-5435

• Registration Number: NCT01517321
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-07
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	MK-0431/ONO-5435	-
P	Placebo, MK-0431/ONO-5435	-

Primary Outcome Measures

Name	Time	Method
Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability	12 weeks and 52 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 weeks
2-hour postmeal glucose	12 weeks
Fasting plasma glucose	12 weeks

Trial Locations

Locations (6)

Tohoku Region Clinical Site; 🇯🇵 Tohoku, Japan

Kinki Region Clinical Site; 🇯🇵 Kinki, Japan

Chubu Region Clinical Site; 🇯🇵 Chubu, Japan

Chugoku Region Clinical Site; 🇯🇵 Chugoku, Japan

Kanto Region Clinical Site; 🇯🇵 Kanto, Japan

Kyusyu Region Clinical Site; 🇯🇵 Kyusyu, Japan