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

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ClinicalTrials.gov Identifier: NCT00782418
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : April 6, 2010
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
The Methodology Assessment of Glucose Dependent Insulin Secretion Drug: Comparator: exenatide Drug: Comparator: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects
Study Start Date : September 2008
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

    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)


  2. Change From Baseline in C-peptide Concentration [ Time Frame: Pre and Post glucose infusion ]
  3. Change From Baseline in Insulin Concentration [ Time Frame: Pre and Post glucose infusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782418


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00782418     History of Changes
Other Study ID Numbers: 0000-104
2008_568
First Posted: October 31, 2008    Key Record Dates
Results First Posted: April 6, 2010
Last Update Posted: December 21, 2016
Last Verified: November 2016

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