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

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.
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Drug: exenatide
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
Other Names:
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Active Comparator: Insulin
The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
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Drug: Insulin
Insulin will be taken according to the subject's current regimen |
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]Change in HbA1c from Baseline study termination (Week 16)

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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 |
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.

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
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 |
Study Director: | James Malone, MD | Eli Lilly and Company |
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 |
exenatide exendin-4 Amylin Eli Lilly diabetes |
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 |