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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01055340 (opens ClinicalTrials.gov in a new tab)Other id0000-159Other id159Other id2010_506
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
12 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Double masking
Countries
Not stated
Start
Apr 2010
Primary completion
May 2010
Completion
Jun 2010
First posted
25 Jan 2010 (estimated)
Last update posted
29 May 2015 (estimated)
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011
  1. Ph 1

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

    NCT01055340

    Apr 2010 to Jun 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxyntomodulin (OXM)Drug
  • Comparator: Oxyntomodulin (OXM)Drug
  • Comparator: Placebo [ hemaccel-containing saline]Drug

Arms6

  • Experimental

    Treatment sequence 1

    OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo

  • Experimental

    Treatment sequence 2

    OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min

  • Experimental

    Treatment sequence 3

    Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min

  • Experimental

    Treatment sequence 4

    OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min

  • Experimental

    Treatment sequence 5

    Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min

  • Experimental

    Treatment sequence 6

    OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Ambient plasma glucose concentration during the GGI

    Time frame · Last 160 minutes of OXM/placebo infusion

  2. plasma βOHB + AcAc concentrations

    Time frame · First 300 minutes of OXM/placebo infusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2018

Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes.

Shankar et al. 2018Diabetescited by 44

PMID 29545266DOI 10.2337/db17-1331PUB-29545266

Rights unknown
Source link

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2016

Linearity of β-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series.

Shankar et al. 2016American journal of physiology. Endocrinology and metabolismcited by 7

PMID 27072496DOI 10.1152/ajpendo.00527.2015PUB-27072496

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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