Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)

• Status: Completed
• Trial end date: 2014-04-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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