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Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00241423
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
Study Start Date : October 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide
Exenatide and the subject's current oral antidiabetic agent regimen
Drug: exenatide
subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
Other Names:
  • Byetta
  • AC2993
  • synthetic enxendin-4

Placebo Comparator: Placebo
Placebo and the subject's current oral antidiabetic agent regimen
Drug: Placebo
subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week




Primary Outcome Measures :
  1. Time-averaged serum glucose during a 24-hour period [ Time Frame: Every half-hour to hour for 24 hours ]
    Time-averaged serum glucose during a 24-hour period


Secondary Outcome Measures :
  1. To compare the effects of exenatide and placebo on serum glucose [ Time Frame: Each half-hour to 2 hours for 24 hours ]
    To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has an HbA1c between 7.0% and 10.0%, inclusive.
  • Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^2.
  • Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion Criteria:

  • Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
  • Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241423


Locations
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00241423     History of Changes
Other Study ID Numbers: H8O-US-GWAW
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: January 2015

Keywords provided by AstraZeneca:
exenatide
diabetes
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists