A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021462
First received: November 25, 2009
Last updated: May 2, 2014
Last verified: May 2014

November 25, 2009
May 2, 2014
August 2007
August 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01021462 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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.
Experimental: Period 1 + Period 2
graded infusion of intravenous glucose
Intervention: Procedure: Comparator: graded infusion of intravenous glucose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2007
August 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01021462
0000-078, 078, 2009_695
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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