Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-8666; Placebo
Intervention description: MK-8666, capsules, oral, QD, Days 1 to 14; Placebo, capsules, oral, QD, Days 1 to 14
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)
      of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in
      this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic
      agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary
      hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a
      dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction
      from baseline is ≥34 mg/dL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, must be either postmenopausal or surgically sterile

          -  A Body Mass Index (BMI) ≥18 kg/m^2 to ≤40 kg/m^2, inclusive.

          -  A diagnosis of T2DM

          -  Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents
             (thiazolidenediones are excluded)

          -  Judged to be in good health except for T2DM

          -  Willing to follow a standard weight maintaining diet throughout the study

          -  A nonsmoker or has not used nicotine or nicotine-containing products for at least 3
             months

        Exclusion Criteria:

          -  A history of clinically significant endocrine (except T2DM), gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
             genitourinary abnormalities or diseases

          -  A history of myositis or complaints including diffuse myalgias, muscle tenderness, or
             weakness.

          -  A history of cancer (malignancy) excepting adequately treated non-melanomatous skin
             carcinoma or carcinoma in situ of the cervix

          -  Has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of
             gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux,
             early satiety)

          -  A history of type 1 diabetes mellitus and/or history of ketoacidosis

          -  Taking a medication for a co-morbid condition that is not permitted during the study

          -  A history of significant multiple and/or severe allergies

          -  Positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus

          -  Had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study
             participation

          -  Participated in another investigational trial within 4 weeks prior to study
             participation

          -  Consumes excessive amounts of alcoholic or caffeine-containing beverages

          -  A regular user of illicit drugs or a history of drug or alcohol abuse within the past
             year