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Completed

NCT Number: NCT01021527

A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)

A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject has irritable bowel disease
  • Subject has a history of cancer
  • Subject has a history of hypertension requiring treatment
  • 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

Treatment and study plan

Comparator: Treatment A

Other

No Treatment

Comparator: Treatment B

Drug

single dose administration of exenatide 5ug by subcutaneous injection

Comparator: Treatment C

Drug

single dose administration of exenatide 10ug by subcutaneous injection

Comparator: graded glucose infusion

Procedure

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 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.

Primary outcomes

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

    Time frame: 0-160 minutes after start of infusion

Secondary outcomes

  1. safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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