Patient-driven doses led to 67.5% of subjects reaching target HbA1C compared to 58.4% in the physician-driven arm.
Results from the TAKE CONTROL randomized trial showed that insulin glargine 300 units/mL (Toujeo, Sanofi), taken with a simple dose patient-driven titration regimen demonstrated better HbA1C control without increasing the risk of hypoglycemia in type 2 diabetes (T2D) patients than patients on a physician-driven titration regimen.
The trial had participants begin with insulin glargine 300 units/mL, or switch from other basal insulins (insulin glargine 100 units/mL, insulin detemir, and NPH) while continuing to take any other oral antidiabetic drugs (OADs). After 6 weeks, the patients using patient-driven titration saw HbA1C improvement over the physician-driven group (LS mean difference 0.13%, p=0.0247).
"The results of the TAKE CONTROL study demonstrate that patients can make a critical contribution to work toward their own effective blood sugar target when they are well trained and using a basal insulin such as Toujeo," Riccardo Perfetti, the vice president of medical affairs and DCV medical affairs at Sanofi, said in a statement.
In the patient-driven group, 67.5% reached the predefined blood glucose target, compared to 58.4% in the physician-driven group (RR 1.15 [1.02; 1.3], p=0.0187). At least one severe and/or confirmed hypoglycemic event was experienced by 6.4% of patient-driven subjects, and 6.3% of physician-driven subjects.
TAKE CONTROL, a 24-week study, included 631 patients with uncontrolled T2D — 62% of which were on basal insulin, 38% were insulin-naïve – with a mean age of 63 and mean duration of diabetes of 12 years. The patient-titration group was also favorable in the secondary endpoints of reaching the 80-130 mg/dL target of pre-defined fasting self-measured plasma glucose (SMPG), without experiencing hypoglycemia at week 24.
At least one episode of hypoglycemia was reported by 36.2% of patients in the patient-driven arm and 37% in the physician-driven arm. Severe incidence of hypoglycemia was reported in 0.6% of the patient-driven arm and 0.3% of the physician-drive arm.
Sanofi is in the process of conducting a Real-World comparative study of more than 200000 patients from the US and EU, with additional evidence expected to be published this year. Two retrospective studies, DELIVER 2 and DELIVER 3, have already been conducted and presented.
Thus far, the study indicates a positive future for patient-driven diabetes management. Full results of the TAKE CONTROL study are expected in 2018.