Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide/insulin glargine; Drug: insulin glargine/exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099619

H8O-MC-GWAO

Details and patient eligibility

About

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Enrollment: 138 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
• HbA1c between 7.1% and 11.0%, inclusive.
• Insulin therapy should be the next appropriate step of diabetes treatment.
• Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

• Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
• Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

exenatide/insulin glargine

Experimental group

Description:

Arm that first receives exenatide, then crosses over to insulin glargine

Treatment:

Drug: exenatide/insulin glargine

Insulin glargine/exenatide

Experimental group

Description:

Arm that first receives insulin glargine, then crosses over to exenatide

Treatment:

Drug: insulin glargine/exenatide