A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Panel Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Patients With Type 2 Diabetes Mellitus

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

Inclusion Criteria:

• Type 2 diabetes
• Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
• male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
• A body mass index (BMI) that is > 20 and ≤ 40 kg/m2

Exclusion Criteria:

• History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
• History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
• Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
• oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
• History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
• History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
• History of significant or unstable cardiovascular disease
• History of neoplastic disease
• History of hepatic disease
• History of seizures, epilepsy or other neurologic disease
• History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder