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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00324363
First received: May 9, 2006
Last updated: June 6, 2014
Last verified: June 2014

May 9, 2006
June 6, 2014
January 2006
Not Provided
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. [ Time Frame: 16 weeks ]
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.
Complete list of historical versions of study NCT00324363 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 16 weeks ]
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
Not Provided
Not Provided
 
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide
    subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
    Other Name: Byetta
  • Drug: Placebo
    subcutaneous injection twice daily in volumes equal to exenatide
  • Experimental: Exenatide
    Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks
    Intervention: Drug: exenatide
  • Placebo Comparator: Placebo
    Placebo in volume equal to exenatide
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
April 2007
Not Provided

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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Korea, Republic of,   Taiwan
 
NCT00324363
H8O-MC-GWBA
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP