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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01055340
First received: January 22, 2010
Last updated: June 17, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • plasma βOHB + AcAc concentrations [ Time Frame: First 300 minutes of OXM/placebo infusion ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055340

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01055340     History of Changes
Other Study ID Numbers: 0000-159, 159, 2010_506
Study First Received: January 22, 2010
Last Updated: June 17, 2014
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014