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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324363
• Other study ID #: H8O-MC-GWBA
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2006
• Last updated: February 20, 2015
• Start date: January 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug AdministrationIndia: Ministry of HealthSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

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 or 10mcg, twice a day for 16 weeks
• Placebo
subcutaneous injection twice daily in volumes equal to exenatide

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Guangzhou
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Sichuan
India	Research Site	Chennai
India	Research Site	Mumbai
India	Research Site	Pune
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Sungnam City
Taiwan	Research Site	Chiayi
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		16 weeks
Secondary	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		16 weeks