Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide

Drug: glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359762

H8O-EW-GWBE

Details and patient eligibility

About

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Enrollment

1,029 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with type 2 diabetes mellitus.
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
HbA1c >=6.5% and <=9.0%.
Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.

Exclusion criteria

Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
Characteristics contraindicating metformin or glimepiride use.
Receiving drugs that directly affect gastrointestinal motility.
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors; *sulfonylurea; *meglitinides