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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.
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 9, 2006
Last updated: February 20, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: exenatide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 466
Study Start Date: January 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide
Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
Other Name: Byetta
Placebo Comparator: Placebo
Placebo in volume equal to exenatide
Drug: Placebo
subcutaneous injection twice daily in volumes equal to exenatide


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00324363

Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Sichuan, China
Research Site
Chennai, India
Research Site
Mumbai, India
Research Site
Pune, India
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Sungnam City, Korea, Republic of
Research Site
Chiayi, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00324363     History of Changes
Other Study ID Numbers: H8O-MC-GWBA
Study First Received: May 9, 2006
Last Updated: February 20, 2015

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017