Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

NCT00082407 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of exenatide to twice-daily biphasic insulin aspart in adults with type 2 diabetes who are already taking sulfonylurea and metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 505 people

Who can join Ages 30–75 · all sexes

Timeline Started 2003-11 · est. completion 2008-07

Where 69 sites · Croatia, Germany, Greece, Italy, Netherlands, Portugal, Romania, Russia, Slovenia, Spain, Taiwan, United Kingdom

What this study is testing ClinicalTrials.gov NCT00082407 ↗

Description as written by the study sponsor.

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
biphasic insulin aspart also known as NovoLog Drug

subcutaneous injection, twice daily; titration to target blood glucose level

Main thing measured	Change in Glcosylated Hemoglobin (HbA1c)
Sponsor	AstraZeneca
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00082407 ↗