Nearly three-quarters of poorly controlled, type 2 diabetic patients reach glycemic targets when they are treated with biphasic insulin aspart 70/30 (NovoMixR), according to preliminary results released here at the 68th Annual Meeting of the American Diabetes Association (ADA).
The data are from the IMPROVETM trial, in which nearly 58,000 type 2 diabetics from eleven countries were prescribed biphasic insulin aspart by their physician in routine practice. The study is the largest observational study in diabetes to date.
Joseph Shaban, MD, chief of medicine at Windsor Regional Hospital in Windsor, Canada, and colleagues elsewhere, analyzed results in 17,313 patients who have thusfar completed the 26-week study.
Of these, 27% had received no earlier treatment, 67% were on oral antidiabetic drugs (OADs) alone, and six percent were receiving insulin with or without OADs.
Results showed that the mean hemoglobin (Hb) A1C in the total cohort improved by 2.6% from baseline to final visit (9.4% to 6.9%). Patients who had been poorly controlled on prior insulin therapy had larger improvements than patients who were first- time insulin users.
Importantly, 71% of patients achieved the ADA-recommended HbA1C goal of less than or equal to 7%, and 49% reached the more stringent goal of less than or equal to 6.5%.
Treatment was associated with a 71% decrease in major hypoglycemic events.
No significant weight change was seen, and biphasic insulin aspart 70/30 insulin dose increased only slightly during the trial (from 0.37 IU/kg at baseline to 0.42 IU/kg at 26 weeks).
Patient quality of life was assessed using the validated Diabetes Medication Satisfaction questionnaire (DiabMedSat) which evaluates relief of burden, relief of symptoms, and effectiveness. At enrollment, the mean patient satisfaction score was 57.2 on a 100-point scale, which increased significantly to 74.5 at the end of the trial.
“While the number of patients with very high HbA1C levels before glycemic control prior to insulin treatment is alarming, it is encouraging that treatment with biphasic insulin aspart 70/30 helps them achieve control in only six months,” Professor Paul Valensi, chief of the department of endocrinology, diabetology, and nutrition at the Jean Verdier Hospital in Bondy, France, said. Professor Valensi is the principal investigator of the trial.
In 2007, there were an estimated 246 million cases of diabetes. The disease is expected to affect 380 million people by 2025. Type 2 diabetes is responsible for about 90% of all cases of diabetes in developed countries and an even higher percentage in developing countries.
Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03 (at) gmail.com