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NCT01517321 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01517321
Other study ID # ONO-5435-17
Secondary ID Japic CTI-111668
Status Completed
Phase Phase 3
First received November 2, 2011
Last updated July 7, 2013

Study information
Verified date July 2013
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 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
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 rapid-acting insulin secretagogue 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

Intervention

Drug:
• MK-0431/ONO-5435
Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
• Placebo, MK-0431/ONO-5435
Double-blind period (12 wks); 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 to 100 mg QD.

Locations
Country Name City State
Japan Chubu Region Clinical Site Chubu
Japan Chugoku Region Clinical Site Chugoku
Japan Kanto Region Clinical Site Kanto
Japan Kinki Region Clinical Site Kinki
Japan Kyusyu Region Clinical Site Kyusyu
Japan Tohoku Region Clinical Site Tohoku

Sponsors (2)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd MSD K.K.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability 12 weeks and 52 weeks Yes
Secondary HbA1c 12 weeks No
Secondary 2-hour postmeal glucose 12 weeks No
Secondary Fasting plasma glucose 12 weeks No
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