Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: sitagliptin phosphate; Drug: Comparator: Sitagliptin; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758069

0431-045

2008_026

MK0431-045

Details and patient eligibility

About

A 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: 80 patients

Sex: All

Ages: 20 to 69 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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80 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo

2

Experimental group

Description:

Sitagliptin 100 mg

Treatment:

Drug: sitagliptin phosphate

3

Experimental group

Description:

Sitagliptin 50 mg

Treatment:

Drug: Comparator: Sitagliptin