Clinical trial NCT00324363: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Official title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
diabetes
Amylin
Lilly
China
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2006-05-11
Enrollment: 466
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.


Eligibility criteria: Inclusion Criteria:

* Treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
* HbA1c between 7.1% and 11.0%, inclusive.
* Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.

Exclusion Criteria:

* Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
* Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
* Have characteristics contraindicating metformin or sulfonylurea use.
* Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
* Have used drugs for weight loss within 1 month of screening.

Primary outcomes:
measure: To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
timeFrame: 16 weeks
Secondary outcomes:
measure: To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Sichuan
country: China
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Sungnam City
country: Korea, Republic of
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
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: Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J, Brodows R. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Res Clin Pract. 2009 Jan;83(1):69-76. doi: 10.1016/j.diabres.2008.09.037. Epub 2008 Nov 18.