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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099333
• Other study ID #: H8O-MC-GWAK
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2004
• Last updated: February 20, 2015
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
• Insulin
Insulin will be taken according to the subject's current regimen

Locations

Country	Name	City	State
United States	Research Site	Butte	Montana
United States	Research Site	Chula Vista	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16	Change in HbA1c from Baseline study termination (Week 16)	Baseline, Week 16	No