Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
Information source: Ono Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: MK-0431/ONO-5435 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ono Pharma Official(s) and/or principal investigator(s):
Mikio Nishii, Study Director, Affiliation: Ono Pharma
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 glimepiride as monotherapy
Clinical Details
Official title: MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride Add-on Study for Patients With Type 2 Diabetes Mellitus
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HbA1csafety tolerability
Secondary outcome: Plasma glucose
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as
monotherapy
Exclusion Criteria:
- Patients with Type 1 diabetes mellitus
Locations and Contacts
Hokkaido Region, Hokkaido, Japan
Tohoku Region, Tohoku, Japan
Kanto Region, Kanto, Japan
Chubu Region, Chubu, Japan
Kinki Region, Kinki, Japan
Chugoku Region, Chugoku, Japan
Shikoku Region, Shikoku, Japan
Kyushu Region, Kyushu, Japan
Additional Information
Starting date: August 2006
Last updated: June 10, 2008
|
