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

• Status: Completed
• Trial end date: 2007-02-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Molecular Mechanisms of Pharmacological Action

Criteria

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