Trials / Completed
CompletedNCT01517321
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | 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. |
Timeline
- First posted
- 2012-01-25
- Last updated
- 2013-07-09
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01517321. Inclusion in this directory is not an endorsement.