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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide

Drug: Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099333

H8O-MC-GWAK

Details and patient eligibility

About

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).

Full 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.

Enrollment

49 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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.