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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01971554
First received: October 14, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-8666
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Type 2 Diabetes Mellitus Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in Fasting Plasma Glucose [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to Day 29 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area Under the Plasma Concentration-Time Curve from Time Zero to 24 Hours (AUC0-24h) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Maximum Plasma Drug Concentration After Dosing (Cmax) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Time to Reach Cmax (Tmax) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8666 (Dose 1)
MK-8666, Dose 1, oral, once a day (QD) for Days 1 to 14.
Drug: MK-8666
MK-8666, capsules, oral, QD, Days 1 to 14
Drug: Placebo
Placebo, capsules, oral, QD, Days 1 to 14
Experimental: MK-8666 (Dose 2)
MK-8666, Dose 2, oral, QD, for Days 1 to 14
Drug: MK-8666
MK-8666, capsules, oral, QD, Days 1 to 14
Drug: Placebo
Placebo, capsules, oral, QD, Days 1 to 14
Experimental: MK-8666 (Dose 3)
MK-8666, Dose 3, oral, QD for Days 1 to 14
Drug: MK-8666
MK-8666, capsules, oral, QD, Days 1 to 14
Drug: Placebo
Placebo, capsules, oral, QD, Days 1 to 14
Placebo Comparator: Placebo
Placebo corresponding to MK-8666 doses, oral, QD for Days 1 to 14
Drug: Placebo
Placebo, capsules, oral, QD, Days 1 to 14

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01971554     History of Changes
Other Study ID Numbers: 8666-003
Study First Received: October 14, 2013
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014