A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00782418
First received: October 29, 2008
Last updated: October 15, 2013
Last verified: October 2013

October 29, 2008
October 15, 2013
September 2008
February 2009   (final data collection date for primary outcome measure)
  • Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose [ Time Frame: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose ] [ Designated as safety issue: No ]

    Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.

    Insulin Secretion Rate (ISR)/ Blood Glucose (BG)

  • Change From Baseline in C-peptide Concentration [ Time Frame: Pre and Post glucose infusion ] [ Designated as safety issue: No ]
  • Change From Baseline in Insulin Concentration [ Time Frame: Pre and Post glucose infusion ] [ Designated as safety issue: No ]
Comparison of GDIS measured after HGC at steady state to GDIS measured after GGI at the highest glucose infusion rate [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00782418 on ClinicalTrials.gov Archive Site
Not Provided
Changes in C-peptide and plasma insulin concentrations measured by HGC [ Time Frame: Pre and Post glucose infusion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
The Methodology Assessment of Glucose Dependent Insulin Secretion.
  • Drug: Comparator: exenatide
    exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.
    Other Name: Byetta
  • Drug: Comparator: exenatide
    exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.
    Other Name: Byetta
  • Drug: Comparator: Placebo
    5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.
  • Active Comparator: 1
    exenatide 5mcg
    Intervention: Drug: Comparator: exenatide
  • Active Comparator: 2
    exenatide 1.5mcg
    Intervention: Drug: Comparator: exenatide
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
  • Subject is judged to be in good health
  • Subject has been a nonsmoker for at least 3 months
  • Subject is willing to avoid strenuous physical activity for the duration of the study

Exclusion Criteria:

  • Subject has a history of high blood pressure requiring treatment
  • Subject has a history of diabetes or a family history of diabetes mellitus
  • Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
  • Subject consumes more than 3 alcoholic beverages per day
  • Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
  • Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
  • Subject has multiple and/or severe allergies to foods or drugs
  • Subject is a regular user of illegal drugs
  • Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00782418
0000-104, 2008_568
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

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