MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: placebo (unspecified); Drug: sitagliptin phosphate; Drug: Comparator: pioglitazone; Drug: Comparator: sitagliptin phosphate (MK0431)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372060

2006_029

0431-055

Details and patient eligibility

About

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Enrollment: 134 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients Have Type 2 Diabetes Mellitus
• On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion criteria

• Patients Have Type 1 Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

134 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

MK0431 + pioglitazone

Treatment:

Drug: Comparator: pioglitazone

Drug: sitagliptin phosphate

2

Placebo Comparator group

Description:

Placebo/MK0431 + pioglitazone

Treatment:

Drug: Comparator: sitagliptin phosphate (MK0431)

Drug: Comparator: placebo (unspecified)

Drug: Comparator: pioglitazone