A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021462
First received: November 25, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

A two period pilot study to determine if a graded glucose infusion using a glucose (20% dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated in healthy subjects.


Condition Intervention Phase
Healthy
Procedure: Comparator: graded infusion of intravenous glucose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, 2-Period, Pilot Study in Healthy Male Subjects to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates

Resource links provided by NLM:


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

Primary Outcome Measures:
  • proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels [ Time Frame: 0-160 minutes after start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) [ Time Frame: 0-160 minutes after start of infusion ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2007
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1 + Period 2
graded infusion of intravenous glucose
Procedure: Comparator: graded infusion of intravenous glucose
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.

  Eligibility

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

Inclusion Criteria:

  • Subject is in good health
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject has a history of hypertension requiring treatment
  • Subject has a history of cancer
  • Subject's parents of siblings have a history of type 2 diabetes
  • Subject is unable to refrain from the use of any prescription or non-prescription medication
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021462

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT01021462     History of Changes
Other Study ID Numbers: 2009_695, 078
Study First Received: November 25, 2009
Last Updated: November 25, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

ClinicalTrials.gov processed this record on April 17, 2014