An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Comparator: sitagliptin 200 mg; Drug: Comparator: sitagliptin 100 mg; Drug: Comparator: pioglitazone; Drug: Comparator: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094757

0431-023

2004_045

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Enrollment: 521 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion criteria

• Younger than 18 years of age or older than 75
• Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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521 participants in 3 patient groups, including a placebo group

Sitagliptin 100 mg

Experimental group

Description:

Sitagliptin 100 mg

Treatment:

Drug: Comparator: sitagliptin 100 mg

Sitagliptin 200 mg

Experimental group

Description:

Sitagliptin 200 mg

Treatment:

Drug: Comparator: sitagliptin 200 mg

Placebo/Pioglitazone

Placebo Comparator group

Description:

Placebo/Pioglitazone

Treatment:

Drug: Comparator: placebo

Drug: Comparator: pioglitazone