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Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

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ClinicalTrials.gov Identifier: NCT00099333
Recruitment Status : Completed
First Posted : December 13, 2004
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide Drug: Insulin Phase 2

Detailed Description:
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy
Study Start Date : February 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide
The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.
 Drug: exenatide
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
Other Names:
  • synthetic exendin-4
  • AC2993
  • Byetta
Active Comparator: Insulin
The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
 Drug: Insulin
Insulin will be taken according to the subject's current regimen


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    Change in HbA1c from Baseline study termination (Week 16)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have been treated with insulin for >=3 months up to 12 years.
  • HbA1c <=10.5%.
  • Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

Exclusion Criteria:

  • Patients previously received exenatide or GLP-1 analogs.
  • Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099333


Locations
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United States, California
Research Site
Chula Vista, California, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
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Study Director: James Malone, MD Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099333    
Other Study ID Numbers: H8O-MC-GWAK
First Posted: December 13, 2004    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: January 2015
Keywords provided by AstraZeneca:
exenatide
exendin-4
Amylin
Eli Lilly
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists