Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

• Patient is not pregnant or breastfeeding

• Male or female patient unlikely to conceive

• Patient not on an antihyperglycemic drug

Exclusion Criteria:

• Patient has history of type 1 diabetes mellitus

• Patient has history of ketoacidosis

• Patient requires insulin within 8 weeks prior to start of study

• Patient on weight loss program and is not in maintenance phase

• Patient taking weight loss medication within 8 weeks prior to start of study

• Patient on or likely to require = 14 days or repeated courses of corticosteroids

• Patient taking immunosuppressive/immunomodulating medication

• Patient taking digoxin or other cardiac medication

• Patient has undergone surgical general anesthesia within 30 days prior to start of study

• Patient taking investigational drug within 8 weeks prior to start of study

• Patient is diagnosed with liver disease

• Patient has chronic myopathy, progressive neurological/neuromuscular disorder

• Patient has with severe cardiac conditions within the last 6 months

• Patient is Human immunodeficiency virus (HIV) positive

• Patient has hematological disorder

• Patient has history of malignancy

• Patient has history of alcohol or drug abuse within the past 3 years