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: May 7, 2014
Last verified: May 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: April 2014
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 7, 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 August 20, 2014