NCT01021462

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

Same day

First QC Date

November 25, 2009

Last Update Submit

July 29, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)

    0-160 minutes after start of infusion

Study Arms (1)

Period 1 + Period 2

EXPERIMENTAL

graded infusion of intravenous glucose

Procedure: Comparator: graded infusion of intravenous glucose

Interventions

Comparator: graded infusion of intravenous glucosePROCEDURE

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.

Period 1 + Period 2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 30, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

July 30, 2015

Record last verified: 2015-07