Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: Rosiglitazone; Drug: Comparator: Placebo; Drug: Comparator: Metformin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541775

2007_623

0431-801

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Enrollment: 273 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient has Type 2 diabetes
• Currently taking metformin >1500 mg/day for at least 10 weeks
• Male or female

Exclusion criteria

• Patient has peripheral edema
• History of type 1 diabetes
• Patient required insulin within prior 8 weeks
• Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
• Participating in a weight loss program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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273 participants in 3 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

sitagliptin 100 mg

Treatment:

Drug: Sitagliptin

Drug: Comparator: Metformin

Rosiglitazone

Active Comparator group

Description:

rosiglitazone 8 mg

Treatment:

Drug: Comparator: Metformin

Drug: Comparator: Rosiglitazone

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Metformin

Drug: Comparator: Placebo