A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Comparator: voglibose; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411554

0431-054

2006_051

Details and patient eligibility

About

The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Enrollment: 319 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion criteria

• Patients have type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 2 patient groups

Sitagliptin 50 mg QD

Experimental group

Description:

sitagliptin 50 mg orally once daily (QD=once daily)

Treatment:

Drug: sitagliptin phosphate

Voglibose 0.2 mg TID

Active Comparator group

Description:

voglibose 0.2 mg orally three times daily (TID= three times daily)

Treatment:

Drug: Comparator: voglibose