Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 17, 2005
June 6, 2014
October 2005
June 2007   (final data collection date for primary outcome measure)
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
- To test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in a lower time-averaged serum glucose during a 24-hour period, compared with placebo.
Complete list of historical versions of study NCT00241423 on ClinicalTrials.gov Archive Site
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
  • - To compare the effects of exenatide and placebo on the following:
  • * various glucose measurements derived from the 24-hour glucose profile
  • * free fatty acids and triglycerides following each controlled meal
  • * incidence of hypoglycemia
  • * adverse events
Not Provided
Not Provided
 
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
  • Experimental: Exenatide
    Exenatide and the subject's current oral antidiabetic agent regimen
    Intervention: Drug: exenatide
  • Placebo Comparator: Placebo
    Placebo and the subject's current oral antidiabetic agent regimen
    Intervention: Drug: Placebo
Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. Epub 2008 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00241423
H8O-US-GWAW
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP