Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111540

2993-119

Details and patient eligibility

About

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Enrollment: 456 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has an HbA1c value <=11.0%
• The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion criteria

• Is currently treated with certain medications, including exogenous insulin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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456 participants in 1 patient group

Exenatide

Experimental group

Description:

Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination

Treatment:

Drug: exenatide