A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: exenatide

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00360334

H8O-BP-GWBG

Details and patient eligibility

About

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Enrollment

235 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with type 2 diabetes
Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
HbA1c between 7.5% and 10.0%.
BMI >27.

Exclusion criteria

Receive 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 study.
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.