Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002 AM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640873
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: MK-8655 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Subjects With Type 2 Diabetes
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MK-8655 Drug: MK-8655
Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (quaque die, q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.

Placebo Comparator: Placebo Drug: Placebo
Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).

Primary Outcome Measures :
  1. Number of Participants with One or More Adverse Events after Single and Multiple Drug Doses [ Time Frame: Up to 14 days after the last dose of study drug ]
  2. Number of Participants Discontinuing Study Drug Due to an Adverse Event after Single and Multiple Drug Doses [ Time Frame: Through Day 16 ]
  3. Change from Baseline to Day 17 in Fasting Plasma Glucose after Multiple Drug Doses [ Time Frame: Baseline and Day 17 ]

Secondary Outcome Measures :
  1. True Geometric Mean Plasma Concentration after Single and Multiple Drug Doses [ Time Frame: Up to Day 17 ]
  2. Change from Baseline to Day 15 in 24-Hour Weighted Mean Glucose after Multiple Drug Doses [ Time Frame: Baseline and Day 15 ]
  3. Change From Baseline in Plasma Glucose Excursion During an Oral Glucose Tolerance Test after Single and Multiple Drug Doses [ Time Frame: Up to Day 17 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01640873     History of Changes
Other Study ID Numbers: 8655-002
MK-8655-002 ( Other Identifier: protocol number )
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes

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