Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide once weekly

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00935532

H8O-JE-GWBX

Details and patient eligibility

About

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Enrollment

427 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

present with type 2 diabetes mellitus
HbA1c between 7.1% and 11.0% inclusive
body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive
treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion criteria

Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
Have been treated with drugs that promote weight loss within 90 days prior to study start.
Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
Have donated blood within 30 days prior to study start.