Phase 1
Completed N=63
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)
Source: ClinicalTrials.gov NCT01971554 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15 — 32.8; 37.9; 56.0; 2.0 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15 |
32.8; 37.9; 56.0; 2.0 | — |
| PRIMARY Number of Participants Who Experienced at Least Once Adverse Event |
3; 9; 10; 5 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h) |
6.11; 37.2; 143; 15.3; 66.9; 172 | — |
| SECONDARY Maximum Plasma Drug Concentration After Dosing (Cmax) |
0.906; 4.49; 17.1; 1.50; 7.16; 19.9 | — |
| SECONDARY Time to Reach Cmax (Tmax) |
2.0; 2.25; 2.5; 2.0; 2.0; 2.0 | — |
| SECONDARY Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15 |
19.0; 27.3; 45.4; -3.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01971554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.