Clinical trial NCT00099320: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
Official title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
exendin-4
diabetes
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2004-12-13
Enrollment: 182
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.


Eligibility criteria: Inclusion Criteria:

* Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
* HbA1c between 7.1% and 10.0%, inclusive.
* Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.

Exclusion Criteria:

* Patient previously in a study using exenatide or GLP-1 analogs.
* Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
* Treated with oral insulin within 3 months of screening.

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of subjects reaching the target HbA1c (<7%)
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
measure: Change in body weight from Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
timeFrame: Baseline, Week 16
measure: Changes in beta cell function and insulin sensitivity between Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Changes in lipids between Baseline and Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: La Jolla
country: United States
facility: Research Site
state: California
city: San Mateo
country: United States
facility: Research Site
state: California
city: Santa Barbara
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Melbourne
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Butte
country: United States
facility: Research Site
state: Montana
city: McCook
country: United States
facility: Research Site
state: Nebraska
city: North Platte
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Scottsbluff
country: United States
facility: Research Site
state: Nebraska
city: Princeton
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Georgetown
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: The Colony
country: United States
facility: Research Site
state: Texas
city: Olympia
country: United States
facility: Research Site
state: Washington
city: Renton
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: Huntington
country: United States
facility: Research Site
state: West Virginia
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Dartmouth
country: Canada
facility: Research Site
state: Nova Scotia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Granada
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
citation: Zinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. doi: 10.7326/0003-4819-146-7-200704030-00003.