Clinical trial NCT00381342: Safety and Efficacy of Exenatide as Monotherapy
Official title: Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Amylin
Lilly
monotherapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2006-09-27
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Treating diabetes with diet and exercise
* HbA1c between 6.5% and 10.0%, inclusive
* Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive

Exclusion Criteria:

* Have previously completed or withdrawn from this study
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have been treated with any antidiabetic agent
* Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
* Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
timeFrame: Baseline, Weeks 4, 8, 12, 16, 24
measure: Change in fasting serum glucose (FSG) from Baseline to Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, and 24
measure: Change in body weight from Baseline to Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, and 24
measure: Change in glucose measurements from Baseline to Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 24
measure: Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, and 24
measure: Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
timeFrame: Immediately before glucose load, then 30, 60, 120, and 180 minutes post
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Aligarh
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Karnal
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Manati
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Alba Iulia
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006.
citation: Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
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.