Patient-Driven Dose Regimen Superior in Type 2 Diabetes

Type 2 Diabetes

A patient-driven titration regimen demonstrated better HbA1C control without increasing the risk of hypoglycemia than a physician-driven titration regimen in patients with type 2 diabetes, according to the results of a recent study.

A 24-week study (TAKE CONTROL) supported by Sanofi included 631 patients with uncontrolled type 2 diabetes. Among these patients, 62% were receiving basal insulin and 38% were insulin naïve. The mean duration of diabetes among all patients was 12 years.

Participants began treatment with insulin glargine (300 units/mL) or switched from other basal insulins (insulin glargine 100 units/mL, insulin detemir, and NPH) while continuing to take any oral antidiabetic drugs of their choosing. The primary objective was to demonstrate noninferiority in terms of glycemic control, measured as change from baseline to week 24 in HbA1C.

After a 6-week period, the patients using the patient-driven titration regimen saw HbA1C improvement compared to the physician-driven group (difference of 13%, P = .0247). In the patient-driven group, 67.5% reached the predefined blood glucose target, compared with 58.4% in the physician-driven group. Rates of hypoglycemic events were comparable both treatment groups (6.4% vs 6.3%, respectively).


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The patient-driven group was also favorable in the secondary endpoints; these patients reached the 80-130 mg/dL target of pre-defined fasting self-measured plasma glucose without experiencing hypoglycemia at week 24.

"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," said Riccardo Perfetti, vice president of medical affairs and DCV medical affairs, Sanofi, in a statement (September 14, 2017).

Further results of the TAKE CONTROL study are expected in 2018, but researchers believe that the data thus far indicate a positive future for patient-driven diabetes management. Sanofi is in the process of conducting a real-world comparative study involving 200,000 multinational patients with type 2 diabetes. Additional evidence is expected to be released this year.—Zachary Bessette