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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00099333
First received: December 10, 2004
Last updated: June 6, 2014
Last verified: June 2014

December 10, 2004
June 6, 2014
February 2004
August 2005   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline study termination (Week 16)
Not Provided
Complete list of historical versions of study NCT00099333 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Drug: Insulin
    Insulin will be taken according to the subject's current regimen
  • Experimental: Exenatide
    The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.
    Intervention: Drug: exenatide
  • Active Comparator: Insulin
    The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
    Intervention: Drug: Insulin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
August 2005
August 2005   (final data collection date for primary outcome measure)

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.
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099333
H8O-MC-GWAK
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