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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

July 12, 2012
December 26, 2013
September 2012
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01640873 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002 AM1)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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.
  • 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).
  • Experimental: MK-8655
    Intervention: Drug: MK-8655
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01640873
8655-002, MK-8655-002
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP