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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324363

H8O-MC-GWBA

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.

Enrollment: 466 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
• HbA1c between 7.1% and 11.0%, inclusive.
• Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

Exclusion criteria

• Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
• Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
• Have characteristics contraindicating metformin or sulfonylurea use.
• Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
• Have used drugs for weight loss within 1 month of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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466 participants in 2 patient groups, including a placebo group

Exenatide

Experimental group

Description:

Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks

Treatment:

Drug: exenatide

Placebo

Placebo Comparator group

Description:

Placebo in volume equal to exenatide

Treatment:

Drug: Placebo