DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); Insulin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16

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.


Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Research Site, Chula Vista, California, United States

Research Site, Butte, Montana, United States

Research Site, Portland, Oregon, United States

Research Site, Nashville, Tennessee, United States

Research Site, San Antonio, Texas, United States

Additional Information

Starting date: February 2004
Last updated: February 20, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017