A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin phosphate; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01034111

2009_705

0431-178

Details and patient eligibility

About

This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.

Enrollment: 30 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with T2DM failing metformin monotherapy
• Between the ages of 18 and 79

Exclusion criteria

• Participants has a history of type 1 Diabetes Mellitus or ketoacidosis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Sitagliptin

Experimental group

Description:

Sitagliptin as add-on therapy to a stable dose of metformin

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate