Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

NCT00434954 · Completed

Last updated 2026-05-28

This clinical trial compared the effects of two diabetes treatments—exenatide plus metformin versus insulin aspart plus metformin—on blood sugar control in adults with type 2 diabetes.

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 494 people

Who can join Ages 18–90 · all sexes

Timeline Started 2007-02 · est. completion 2009-06

Where 39 sites · Germany

What this study is testing ClinicalTrials.gov NCT00434954 ↗

Description as written by the study sponsor.

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Treatments tested

exenatide twice daily (BID) also known as Byetta Drug

subcutaneous injection (5 mcg or 10 mcg), twice a day
premixed insulin aspart twice daily (BID) Drug

subcutaneous injection (titrated appropriately), twice a day

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

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00434954 ↗