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Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

This study has been completed.

Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00359879
  Purpose

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: exenatide
Phase III

MedlinePlus related topics:   Diabetes   

Drug Information available for:   Exenatide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

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

Primary Outcome Measures:
  • To test the hypothesis that glycemic control achieved with exenatide administered subcutaneously before lunch and dinner is noninferior to that obtained with the administration before breakfast and dinner in patients with type 2 diabetes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare exenatide administered either before breakfast and dinner or before lunch and dinner with respect to various pharmacodynamic measurements, body weight, and safety and tolerability. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   400
Study Start Date:   September 2006
Study Completion Date:   July 2007
Primary Completion Date:   July 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
2: Active Comparator Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes.
  • Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion Criteria:

  • Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
  • Have characteristics contraindicating metformin, SU, or TZD use.
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
  • Have used any prescription drug to promote weight loss within 3 months prior to screening.
  • Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359879

Locations
Brazil
Research Site    
      Sao Paulo, Brazil
Research Site    
      Rio de Janeiro, Brazil
Research Site    
      Curitiba, Brazil
Research Site    
      Sao Jose Do Rio Preto, Brazil
Research Site    
      Fortaleza, Brazil
Research Site    
      Goiania, Brazil
Research Site    
      Campinas, Brazil
Research Site    
      Porto Alegre, Brazil
Research Site    
      Salvador, Brazil
Mexico
Research Site    
      Mexico City, Mexico
Research Site    
      Aguascalientes, Mexico
Research Site    
      San Luis Potosi, Mexico
Mexico, Jalisco
Research Site    
      Guadalajara, Jalisco, Mexico
Mexico, Nuevo Leon
Research Site    
      Monterrey, Nuevo Leon, Mexico
Mexico, Yucatan
Research Site    
      Merida, Yucatan, Mexico

Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company

Investigators
Study Director:     James Malone, MD     Eli Lilly and Company    
  More Information


Link to study results on ClinicalStudyResults.org  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:   H8O-CR-GWBH
First Received:   August 1, 2006
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00359879
Health Authority:   Mexico: Ministry of Health;   Brazil: Ministry of Health

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes  
exenatide  
Lilly  
Amylin  

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008




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