The European Exenatide study of long-term exenatide vs. glimepiride for type 2 diabetes: rationale and patient characteristics.
OBJECTIVE
To describe the rationale for the European Exenatide (EUREXA) clinical study and describe the characteristics of the patient cohort.


METHODS
EUREXA is a multinational study of long-term effects of add-on exenatide vs. glimepiride in patients with type 2 diabetes and failure of diet/lifestyle plus metformin monotherapy. Metformin failure was defined as hemoglobin A1c (HbA1c) > or = 6.5% and patients were overweight/obese (BMI > or = 25 to < 40 kg/m(2)). The primary end point is time to failure of combination treatment, defined from HbA1c concentration according to current criteria. At baseline, an oral glucose tolerance test (OGTT) was performed, fasting blood was taken for lipid profile and patients were randomized to add-on exenatide (5 microg b.i.d. for 4 weeks then 10 microg b.i.d.) or glimepiride (1 mg/day titrated to maximum dose).


RESULTS
A total of 1039 patients were entered in the study, with mean (+/- s.d.) age 57.2 +/- 9.6 years, body mass index (BMI) 32.4 +/- 4.1 kg/m(2), duration of diabetes 5.6 +/- 4.5 years and HbA1c 7.4 +/- 0.7%. A history of cardiovascular disease (CVD) was present for 64.8% of patients overall and duration of diabetes was statistically significantly longer for patients with CVD than without (p = 0.010). Lipid abnormalities were reported for 48.9% of patients and 40.9% were taking at least one lipid-lowering medication.


CONCLUSIONS
Patients included in the EUREXA study had early failure of glucose control with metformin and presented typical features of type 2 diabetes: overweight/obesity and high prevalence of lipid abnormalities and CVD. In this population, the effects of exenatide vs. glimepiride will be evaluated over at least 2.5 years.
Kazda
C
C
Lilly Deutschland GmbH, 61352 Bad Homburg, Germany. Kazda_Christof@Lilly.com
Gallwitz
B
B
Simó
R
R
Guzmán
J R
JR
Kraus
P
P
Nicolay
C
C
Rose
L
L
Schernthaner
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005060:Europe; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D014688:Venoms / Q000627:therapeutic use*; D055815:Young Adult
D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; D013453:Sulfonylurea Compounds; D014688:Venoms; C057619:glimepiride