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: April 29, 2014
Last verified: April 2014
  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
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: 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: April 29, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014