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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055340
First Posted: January 25, 2010
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Obesity Drug: Oxyntomodulin (OXM) Drug: Comparator: Oxyntomodulin (OXM) Drug: Comparator: Placebo [ hemaccel-containing saline] Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 12
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055340


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01055340     History of Changes
Other Study ID Numbers: 0000-159
159
2010_506
First Submitted: January 22, 2010
First Posted: January 25, 2010
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Ketogenesis
Glucose-Dependent Insulin Secretion
Graded Glucose Infusion
Oxyntomodulin

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs