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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 19, 2005
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
- 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1185/030079908X297268 . Epub 2008 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
30
Original Enrollment  ICMJE
 (submitted: October 17, 2005)
38
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00241423
Other Study ID Numbers  ICMJE H8O-US-GWAW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: James Malone, MD Eli Lilly and Company
PRS Account AstraZeneca
Verification Date January 2015

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