A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0893; Metformin; Placebo; Placebo
Intervention description: 10 mg and 100 mg tablets; 500 mg metformin tablets; Placebo tablets matching MK-0893; Placebo tablets matching metformin
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Therapeutic Uses; Pharmacologic Actions; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Metformin

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.
    

Eligibility 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