Abstract
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.
Highlights
Diabetes is a major global public health concern and has been recognized as the biggest epidemic of the 21st century
Patient-led adjustment of Glargine-U-100 in outpatient setting can be a safe and effective method for glycemic control in Indian patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetes drug (OAD)
Patients were included in the study if they (1) were insulin-naive with T2DM for at least 2 years; (2) had suboptimal diabetes control, despite receiving stable doses of two OADs for more than 3 months before randomization; (3) had body mass index (BMI) ‡20 and £40 kg/m2; and (4) were eligible to receive basal long-acting insulin for the control of hyperglycemia
Summary
Diabetes is a major global public health concern and has been recognized as the biggest epidemic of the 21st century. The Asian Treat to Target Lantus Study (ATLAS) was designed and conducted to examine the safety and benefits of Glargine-U-100 titration regimen in patient- versus physician-led management setup.[16] The consolidated results of the ATLAS showed that compared with physician-led titration, a simple patient-led titration algorithm confers significantly improved glycemic control with a low incidence of severe hypoglycemia.[14]. 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). 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
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