MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: placebo; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289848

2005_094

MK0431-040

0431-040

Details and patient eligibility

About

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Enrollment: 530 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion Criteria :

• Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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530 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

sitagliptin 100 mg

Treatment:

Drug: sitagliptin phosphate

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: placebo