Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Insulin glargine; Drug: exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097500

2993-114

Details and patient eligibility

About

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Enrollment: 69 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes, but otherwise healthy
• HbA1c between 6.6% and 9.5%, inclusive.
• Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
• Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion criteria

• Patients previously in a study using exenatide.
• Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
• Treated with insulin within 3 months of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Exenatide Arm

Experimental group

Description:

Exenatide and Metformin

Treatment:

Drug: exenatide

Drug: Metformin

Insulin Glargine Arm

Active Comparator group

Description:

Insulin Glargine and Metformin

Treatment:

Drug: Metformin

Drug: Insulin glargine