Background: Titration of basal insulin led by either the physician or the patient is not well understood in India. This analysis of Indian subset of Asian Treat to Target Lantus Study (ATLAS) compared effectiveness of patient-led with physician-led titration of once-daily insulin glargine 100 U/mL (Glargine-U-100) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetes drug (OAD). Methods: In this open-label parallel group study, randomized patients (either physician-led or patient-led [self-titration] group) followed the same dose titration algorithm (fasting blood glucose [FBG] target 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led group versus the physician-led group. Results: Patients (40-75 years) were randomized to either the physician-led group (n = 39) or the patient-led group (n = 36). At week 24, self-titration led to a greater decline in HbA1c than physician-led titration (-1.3% vs. -1.1%). Mean decrease in FBG was more in the patient-led group than in the physician-led group (-53.7 mg/dL vs. -35.5 mg/dL). Mean daily dose of Glargine-U-100 at week 24 was higher in the patient-led group than in the physician-led group (30.0 U vs. 23.8 U). At any time during the study, 30.6% and 7.7% of patients in the patient-led and physician-led groups, respectively, showed target HbA1c level of <7.0% without severe hypoglycemia. Treatment satisfaction and quality of life improved in both groups. Overall, treatment was safe and well tolerated, and none of the events led to treatment discontinuation. Conclusion: Patient-led adjustment of Glargine-U-100 in outpatient setting can be a safe and effective method for glycemic control in Indian patients with T2DM uncontrolled on OADs.
Keywords: HbA1c; Patient-led insulin titration; Phase IV study; Physician-led insulin titration; Type 2 diabetes mellitus.