Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

August 31, 2005

Study Completion Date

August 31, 2005

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

exenatide

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units \[5 μg\] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units \[10 μg\] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.

DRUG

Placebo

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

Trial Locations (51)

Unknown

Research Site, Birmingham

Research Site, La Jolla

Research Site, San Mateo

Research Site, Santa Barbara

Research Site, Spring Valley

Research Site, Hialeah

Research Site, Jacksonville

Research Site, Melbourne

Research Site, West Palm Beach

Research Site, Atlanta

Research Site, Honolulu

Research Site, Idaho Falls

Research Site, Chicago

Research Site, Baton Rouge

Research Site, Kalamazoo

Research Site, Troy

Research Site, Butte

Research Site, McCook

Research Site, North Platte

Research Site, Omaha

Research Site, Scottsbluff

Research Site, Princeton

Research Site, Albuquerque

Research Site, Albany

Research Site, New York

Research Site, Rochester

Research Site, Greenville

Research Site, Cleveland

Research Site, Greenville

Research Site, Chattanooga

Research Site, Knoxville

Research Site, Dallas

Research Site, Georgetown

Research Site, San Antonio

Research Site, The Colony

Research Site, Olympia

Research Site, Renton

Research Site, Tacoma

Research Site, Charleston

Research Site, Huntington

Research Site, Calgary

Research Site, Vancouver

Research Site, Dartmouth

Research Site, London

Research Site, Toronto

Research Site, Montreal

Research Site, Granada

Research Site, Seville

Research Site, Valencia

Research Site, Valladolid

Research Site, Zaragoza

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

AstraZeneca

INDUSTRY