A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

May 28, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
  • Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
  • Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study

Exclusion Criteria:

  • Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
  • Subject has a history of hypertension requiring treatment
  • Subject has a history of cancer
  • Subject has history of diabetes, or family history of diabetes mellitus
  • Subject has a history of hypersensitivity to OXM or hemaccel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment sequence 1
OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Experimental: Treatment sequence 2
OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Experimental: Treatment sequence 3
Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Experimental: Treatment sequence 4
OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Experimental: Treatment sequence 5
Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Experimental: Treatment sequence 6
OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
Drug: Oxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
Drug: Comparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
Drug: Comparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ambient plasma glucose concentration during the GGI
Time Frame: Last 160 minutes of OXM/placebo infusion
Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
Time Frame: First 300 minutes of OXM/placebo infusion
First 300 minutes of OXM/placebo infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0000-159
  • 159
  • 2010_506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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