An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Comparator: glipizide; Drug: sitagliptin (MK0431)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094770

0431-024

2004_049

MK0431-024

Details and patient eligibility

About

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Full description

The duration of treatment is 104 weeks.

Enrollment: 1,172 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,172 participants in 2 patient groups

Sitagliptin 100 mg

Experimental group

Description:

Sitagliptin 100 mg oral tablets of sitagliptin once daily.

Treatment:

Drug: sitagliptin (MK0431)

Glipizide

Active Comparator group

Description:

Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

Treatment:

Drug: Comparator: glipizide