Usage of Glimepiride/Metformin Fixed-dose Combination with Insulin in Management of Type 2 Diabetes Mellitus: An Indian Experience

Background: Type 2 diabetes mellitus (T2DM) poses a major public health burden. The present case-based questionnaire survey evaluated the treatment pattern and clinical experience of healthcare professionals (HCPs) in prescribing glimepiride/metformin fixed-dose combination (FDC) with insulin, with or without other oral hypoglycemic agents (OHAs), to patients with T2DM in the Indian setting. Material and methods: A retrospective, multicenter, observational, case-based questionnaire survey was conducted at several healthcare centers in India with the help of medical records of patients having T2DM, who were prescribed different strengths of glimepiride/metformin FDC. Data was collected from the patients’ medical records and were analyzed using statistical tests. Results: A total of 1,013 patients with T2DM were included in this study. The mean (± standard deviation [SD]) age of patients was 53.5 ± 13.9 years. Mean duration of diabetes was 6.3 ± 4.8 years. About 70.1% of the patients received glimepiride/metformin FDC as first-line therapy and 29.9% received it as second-line therapy. Around 66.3% of the patients in first-line glimepiride/metformin FDC group received insulin once a day, and the proportion increased to 86.8% of the patients in second-line therapy group. Other OHAs were used in 754 (74.4%) patients. About 18.2% (n = 185) patients reported change in weight, with a slightly larger number of patients having reduction in weight. There was considerable reduction in HbA1c, FPG and PPG in patients receiving glimepiride/metformin FDC with insulin, irrespective of OHA use. Efficacy and tolerability were reported as good to excellent for 96.2% and 94.8% patients, respectively. Conclusion: This case-based questionnaire survey shows the usage pattern of various strengths of glimepiride/metformin FDC with insulin and the HCPs’ practice approach regarding early initiation of this combination in Indian patients with T2DM

Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study

Background This study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18–60 years) and elderly (>61 years) participants. Method This phase III study was conducted from March 2018 to April 2018 across 12 sites in India. In this randomized, observer-blind, active-controlled study, 480 participants were randomized to receive a single dose of test vaccine (subunit, inactivated influenza vaccine; Influvac® Tetra, Abbott) (n = 240) or reference vaccine (split virion, inactivated influenza vaccine; VaxiFlu-4, Zydus Cadilla Healthcare) (n = 240). The primary objective was to describe and compare the immunogenicity of each vaccination group based on hemagglutination inhibition (HI) assay seroprotection and seroconversion rates, and geometric mean fold increase (GMFI) against four vaccine strains in two age groups. Safety and reactogenicity were also compared for the vaccines in both the age groups. Results The pre- and post-vaccination HI titers for both the vaccines were comparable. The GMFI varied from 4.3 – 22.7 in the test and 3.7–21.6 in the reference vaccine group. The seroprotection rates were >90% for the A-strains and ranged between >43% and <60% for B-strains for both the vaccines. Seroconversion rates varied between 41.4% and 78.8%. Overall, the reported adverse events (AEs) for both the vaccines were <1% and comparable. Reported local and systemic reactions were comparable. Conclusion Influvac® Tetra elicited an adequate immune response with a favorable safety profile which was comparable with the reference vaccine. (Clinical trial registry number: CTRI/2018/02/012222