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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK-8666; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01971554

8666-003

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 4 patient groups, including a placebo group

MK-8666 50 mg

Experimental group

Description:

MK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14.

Treatment:

Drug: MK-8666

Drug: Placebo

MK-8666 150 mg

Experimental group

Description:

MK-8666, 150 mg, oral, QD, for Days 1 to 14

Treatment:

Drug: MK-8666

Drug: Placebo

MK-8666 500 mg

Experimental group

Description:

MK-8666, 500 mg, oral, QD for Days 1 to 14

Treatment:

Drug: MK-8666

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo, oral, QD for Days 1 to 14

Treatment:

Drug: Placebo