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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):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00324363
First received: May 9, 2006
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

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
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324363

Locations
China
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Sichuan, China
India
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
Taiwan
Research Site
Chiayi, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00324363     History of Changes
Other Study ID Numbers: H8O-MC-GWBA
Study First Received: May 9, 2006
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
India: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Amylin Pharmaceuticals, LLC.:
exenatide
diabetes
Amylin
Lilly
China

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Exenatide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013