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A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01055340
First received: January 22, 2010
Last updated: June 10, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01055340     History of Changes
Other Study ID Numbers: 2010_506, 159
Study First Received: January 22, 2010
Last Updated: June 10, 2010
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Merck:
Ketogenesis
Glucose-Dependent Insulin Secretion
Graded Glucose Infusion
Oxyntomodulin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013