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

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Sitagliptin 100 mg/100 mg
Sitagliptin 200 mg/200 mg
Placebo/Sitagliptin 100 mg
Placebo/Sitagliptin 200 mg
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.