Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099320

H8O-MC-GWAP

Details and patient eligibility

About

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Enrollment: 182 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
• HbA1c between 7.1% and 10.0%, inclusive.
• Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion criteria

• Patient previously in a study using exenatide or GLP-1 analogs.
• Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
• Treated with oral insulin within 3 months of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

Exenatide

Experimental group

Description:

After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen

Treatment:

Drug: exenatide

Placebo

Placebo Comparator group

Description:

After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.

Treatment:

Drug: Placebo