A Phase 3 interventional study of Placebo and Sitagliptin phosphate in Type 2 Diabetes Mellitus, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 8 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
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 195 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: Placebo
Drug: Sitagliptin phosphate
Double-blind period (12 wk); 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 QD to 100 mg QD
Double-blind period (12 wk); 50 mg 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 QD to 100 mg QD
HbA1c
Time frame: 12 weeks
safety
Time frame: 52 weeks
tolerability
Time frame: 52 weeks
Plasma glucose
Time frame: 12 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