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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241423
• Other study ID #: H8O-US-GWAW
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2005
• Last updated: February 20, 2015
• Start date: October 2005
• Est. completion date: June 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
• 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

Locations

Country	Name	City	State
United States	Research Site	San Antonio	Texas
United States	Research Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-averaged serum glucose during a 24-hour period	Time-averaged serum glucose during a 24-hour period	Every half-hour to hour for 24 hours	No
Secondary	To compare the effects of exenatide and placebo on serum glucose	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	Each half-hour to 2 hours for 24 hours	No