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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014