PMID- 31335198 OWN - NLM STAT- MEDLINE DCOM- 20200721 LR - 20221207 IS - 1557-8593 (Electronic) IS - 1520-9156 (Linking) VI - 21 IP - 11 DP - 2019 Nov TI - Effectiveness and Safety of Physician-Led Versus Patient-Led Titration of Insulin Glargine in Indian Patients with Type 2 Diabetes Mellitus: A Subanalysis of the Asian Treat to Target Lantus Study (ATLAS). PG - 656-664 LID - 10.1089/dia.2019.0037 [doi] AB - 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. FAU - Misra, Anoop AU - Misra A AD - Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India. FAU - Patel, Mayur AU - Patel M AD - All India Institute of Diabetes and Research, Swasthya Diabetes Care, Jay Mangal Society, Ahmedabad, India. FAU - Agarwal, Pankaj AU - Agarwal P AD - Hormone Care and Research Centre SB-5, Ghaziabad, India. FAU - Lodha, Sailesh AU - Lodha S AD - Dear Foundation, Jaipur, India. FAU - Tandon, Nikhil AU - Tandon N AD - Department of Endocrinology, 3rd Floor Biotechnology Block, AIIMS, New Delhi, India. FAU - Magdum, Mohan AU - Magdum M AD - Jehangir Clinical Development Pvt. Ltd., Jehangir Hospital, Pune, India. FAU - Yajnik, Chittaranjan AU - Yajnik C AD - Diabetes Unit, KEM hospital Research Centre, Pune, India. FAU - Ghosh, Romik AU - Ghosh R AD - Medical Affairs Department, Sanofi, Mumbai, India. FAU - Walekar, Ajit AU - Walekar A AD - Clinical Study Unit, Sanofi, Mumbai, India. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20190809 PL - United States TA - Diabetes Technol Ther JT - Diabetes technology & therapeutics JID - 100889084 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (hemoglobin A1c protein, human) RN - 2ZM8CX04RZ (Insulin Glargine) SB - IM MH - Adult MH - Aged MH - Algorithms MH - Blood Glucose/*drug effects MH - *Blood Glucose Self-Monitoring MH - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology MH - Female MH - Glycated Hemoglobin/*drug effects MH - Humans MH - Hypoglycemia/blood/drug therapy/epidemiology/*prevention & control MH - Hypoglycemic Agents/*administration & dosage MH - India/epidemiology MH - Insulin/administration & dosage/analogs & derivatives MH - Insulin Glargine/*administration & dosage MH - Male MH - Middle Aged MH - Patient Satisfaction/statistics & numerical data MH - Retrospective Studies MH - Self Administration/statistics & numerical data MH - Treatment Outcome OTO - NOTNLM OT - HbA1c OT - Patient-led insulin titration OT - Phase IV study OT - Physician-led insulin titration OT - Type 2 diabetes mellitus EDAT- 2019/07/25 06:00 MHDA- 2020/07/22 06:00 CRDT- 2019/07/24 06:00 PHST- 2019/07/25 06:00 [pubmed] PHST- 2020/07/22 06:00 [medline] PHST- 2019/07/24 06:00 [entrez] AID - 10.1089/dia.2019.0037 [doi] PST - ppublish SO - Diabetes Technol Ther. 2019 Nov;21(11):656-664. doi: 10.1089/dia.2019.0037. Epub 2019 Aug 9.