A Phase 3 interventional study of MK-0431/ONO-5435 and MK-0431/ONO-5435 in Type 2 Diabetes Mellitus, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by Ono Pharmaceutical Co. Ltd · Phase 3, Interventional, and Treatment
This Phase III clinical trial will examine the efficacy, safety, and tolerability 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 insulin monotherapy.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 266 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ono Pharmaceutical Co. Ltd is the lead sponsor of 66 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MK-0431/ONO-5435
Drug: MK-0431/ONO-5435
Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD
Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
HbA1c
Time frame: 16 weeks
Safety and Tolerability
Time frame: 16 weeks and 52 weeks
2 hour post-meal glucose
Time frame: 16 weeks
Fasting plasma glucose
Time frame: 16 weeks
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Ono Pharmaceutical Co. Ltd