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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Comparator: graded infusion of intravenous glucose

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels	0-160 minutes after start of infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)	0-160 minutes after start of infusion

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): August 1, 2007
• Study Completion (ACTUAL): September 1, 2007

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 25, 2009
• First Posted (ESTIMATE): November 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0000-078; 078; 2009_695