Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: exenatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359879

H8O-CR-GWBH

Details and patient eligibility

About

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

Enrollment

377 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with type 2 diabetes.
Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
HbA1c between 7.1% and 10.0%, inclusive.
Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion criteria

Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
Have characteristics contraindicating metformin, SU, or TZD use.
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility