Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Exenatide LAR; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00103935

2993LAR-104

Details and patient eligibility

About

Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
• Has HbA1c of 7.1% to 11.0%, inclusive.
• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

Exclusion criteria

• Received any investigational drug within 3 months prior to screening.
• Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
• Participated previously in an exenatide clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 4 patient groups, including a placebo group

Group A1

Placebo Comparator group

Description:

Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR

Treatment:

Drug: placebo

Drug: placebo

Group A2

Placebo Comparator group

Description:

Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR

Treatment:

Drug: placebo

Drug: placebo

Group B

Experimental group

Description:

Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

Treatment:

Drug: Exenatide LAR

Drug: Exenatide LAR

Group C

Experimental group

Description:

Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

Treatment:

Drug: Exenatide LAR

Drug: Exenatide LAR