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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:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00099333
First received: December 10, 2004
Last updated: February 20, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: exenatide Drug: Insulin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]Change in HbA1c from Baseline study termination (Week 16)
| Enrollment: | 49 |
| Study Start Date: | February 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years (Adult, Senior) |
| 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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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 ClinicalTrials.gov identifier: NCT00099333
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099333
Locations
| 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
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00099333 History of Changes |
| Other Study ID Numbers: |
H8O-MC-GWAK |
| Study First Received: | December 10, 2004 |
| Last Updated: | February 20, 2015 |
Keywords provided by AstraZeneca:
|
exenatide exendin-4 Amylin Eli Lilly diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc Exenatide |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 20, 2017