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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01640873
First received: July 12, 2012
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: MK-8655
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to an Adverse Event after Single and Multiple Drug Doses [ Time Frame: Through Day 16 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Day 17 in Fasting Plasma Glucose after Multiple Drug Doses [ Time Frame: Baseline and Day 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • True Geometric Mean Plasma Concentration after Single and Multiple Drug Doses [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 15 in 24-Hour Weighted Mean Glucose after Multiple Drug Doses [ Time Frame: Baseline and Day 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01640873     History of Changes
Other Study ID Numbers: 8655-002, MK-8655-002
Study First Received: July 12, 2012
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 23, 2014