A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

• Status: Completed
• Trial end date: 2010-08-09
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 18 - 78 years of age

• Currently on metformin monotherapy

Exclusion Criteria:

• History of Type 1 diabetes mellitus or ketoacidosis

• Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks

• Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery

• Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks

• History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease

• HIV positive

• Pregnant, breast-feeding or planning to become pregnant during the study

• User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence