Study design and baseline characteristics of patients in the PRESENT study

Abstract

PRESENT (Physicians' Routine Evaluation of Safety & Efficacy of NovoMix 30 Therapy) is a 6-month observational study of safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in 31,044 type 2 diabetes patients from 15 countries. The aim of this article is to describe the study protocol and assess baseline characteristics of patients in various countries according to diabetes duration (<5 years, 5 to <or=10 years, 10 to <or=20 years and >or=20 years), to improve treatment decisions in clinical practice. Glycaemic control was similar across all groups: HbA1c 9.3-9.4%; fasting plasma glucose 11.3-11.6 mmol/L; postprandial glucose 15.9-16.3 mmol/L. Major hypoglycaemia was reported by 5% of all patients, minor hypoglycaemia increased with diabetes duration (25.4-30.3%); overall hypoglycaemia rate was 6.7 events/patient/year. Complications increased with diabetes duration; the most reported were hypertension (40.6-71.0%) and hyperlipidaemia (39.4-56.6%). Of patients 38% previously received OADs only, 28% insulin only, 19% insulin with OADs, and 13% received no therapy. Glycaemic control appeared independent of diabetes duration. HbA1c was well above targets and the clinical inertia was quite apparent; even patients with diabetes for <5 years had high HbA1c levels. Patients suffered high rates of complications and hypoglycaemia before starting BIAsp 30 therapy.