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
  Purpose

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.


Condition Intervention Phase
The Methodology Assessment of Glucose Dependent Insulin Secretion.
Drug: Comparator: exenatide
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
exenatide 5mcg
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
Active Comparator: 2
exenatide 1.5mcg
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
Placebo Comparator: 3
Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782418

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: NCT00782418     History of Changes
Other Study ID Numbers: 0000-104, 2008_568
Study First Received: October 29, 2008
Results First Received: March 19, 2010
Last Updated: October 15, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014