Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: metformin hydrochloride; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449930

0431-049

2006_561

MK0431-049

Details and patient eligibility

About

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Enrollment: 1,050 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

• Patient has type 2 diabetes mellitus (T2DM)
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,050 participants in 2 patient groups

1

Experimental group

Description:

Drug

Treatment:

Drug: sitagliptin phosphate

2

Active Comparator group

Description:

Active comparator

Treatment:

Drug: Comparator: metformin hydrochloride