Skip to main content
OpenTrials
Completed

NCT Number: NCT01640873

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8655

Drug

Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (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

Drug

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 outcomes

  1. Number of Participants With One or More Adverse Events

    Time frame: Up to 14 days after the last dose of study drug (Up to 31 days)

    An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  2. Number of Participants Discontinuing Study Drug Due to an Adverse Event

    Time frame: Up to 17 days

    An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  3. Fasting Plasma Glucose (FPG)

    Time frame: Day 16 (Predose)

    Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.

Secondary outcomes

  1. True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)

    Time frame: 24 hours post dose on Days 1, 7, and 14

    C24hr was log transformed and analyzed based on a linear mixed effects model containing fixed effects for treatment, day and treatment by day interaction and a random effect for the participant.

  2. 24-Hour Weighted Mean Glucose (WMG)

    Time frame: Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.

    The WMG provides an integrated assessment of the glycemic exposure over the 24-hour period. To reduce variability of the baseline (before any study drug administration) WMG, participants were domiciled in the test facility at least 36 hours prior to Day 1, where standard meals were provided, and physical activity was monitored. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The sample scheme for the 18 point glucose measurements used in this study had many samples taken in the very early morning hours, as well as the first three hours after meals. WMG was calculated as the area under the curve (AUC) of the glucose concentrations divided by the duration of time of samples collected.

  3. Change From Baseline at 2 Hours Oral Glucose Tolerance Test

    Time frame: Baseline and 2 hours after dosing on Days 1, 3, and 16

    Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2012
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.