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

January 22, 2010
June 10, 2010
April 2010
May 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01055340 on ClinicalTrials.gov Archive Site
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A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • 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 1
    OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
  • Experimental: Treatment sequence 2
    OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
  • Experimental: Treatment sequence 3
    Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
  • Experimental: Treatment sequence 4
    OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
  • Experimental: Treatment sequence 5
    Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
  • Experimental: Treatment sequence 6
    OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
    Interventions:
    • Drug: Oxyntomodulin (OXM)
    • Drug: Comparator: Oxyntomodulin (OXM)
    • Drug: Comparator: Placebo [ hemaccel-containing saline]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01055340
2010_506, 159
No
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP