Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin human Exenatide

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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: 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

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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

Davis SN, Johns D, Maggs D, Xu H, Northrup JH, Brodows RG. Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care. 2007 Nov;30(11):2767-72. Epub 2007 Jun 26.


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
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


exenatide exendin-4 Amylin Eli Lilly diabetes

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Exenatide Insulin	Insulin, Globin Zinc Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015