MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Voglibose; Drug: Comparator: Placebo; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00837577

2009_535

0431-104

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups

Sitagliptin/Sitagliptin

Experimental group

Treatment:

Drug: Voglibose

Drug: Sitagliptin

Placebo/Sitagliptin

Experimental group

Treatment:

Drug: Comparator: Placebo

Drug: Voglibose

Drug: Sitagliptin