Phase 3
Completed N=133
MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00837577 ↗
Enrolled (actual)
133
Serious AEs
3.4%
Results posted
Sep 2011
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 — -0.76; 0.16 Percentage of glycosylated hemoglobin — p=<.001
Summary
The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 |
-0.76; 0.16 | <.001 sig |
| SECONDARY Change From Baseline in 2-hour Postprandial Glucose at Week 12 |
-55.3; -4.0 | <.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
-22.6; -0.1 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy
Exclusion Criteria
- Patients Have A History Of Type 1 Diabetes Mellitus
Data sourced from ClinicalTrials.gov (NCT00837577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.