Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: MK-8655; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640873

MK-8655-002 (Other Identifier)

8655-002

Details and patient eligibility

About

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of non-child bearing potential
• Body Mass Index ≤40 kg/m^2
• Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
• In good health except for T2DM
• Willing to follow a standard diet
• Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

Exclusion criteria

• Mentally or legally incapacitated
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic or myeloproliferative diseases
• Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
• Has a history of Type 1 Diabetes and/or history of ketoacidosis
• Use of any lipid-lowering therapies in the past 3 months
• Non-permitted medication for a co-morbid condition
• Excessive alcohol or caffeine use
• Participation in another investigational study within 4 weeks prior to this study
• A history of significant multiple and/or severe allergies or anaphylactic reactions
• Regular user of any illicit drugs or history of alcohol abuse within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

MK-8655 80 mg/MK-8655 320 mg

Experimental group

Description:

Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Treatment:

Drug: MK-8655

Placebo

Placebo Comparator group

Description:

Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Treatment:

Drug: Placebo