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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241423
First received: October 17, 2005
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time-averaged serum glucose during a 24-hour period [ Time Frame: Every half-hour to hour for 24 hours ] [ Designated as safety issue: No ]
    Time-averaged serum glucose during a 24-hour period


Secondary Outcome Measures:
  • To compare the effects of exenatide and placebo on serum glucose [ Time Frame: Each half-hour to 2 hours for 24 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: October 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: October 17, 2005
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
exenatide
diabetes
Amylin
Lilly

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

ClinicalTrials.gov processed this record on November 20, 2014