{"doi":"10.21203/rs.3.rs-1798584/v1","title":"Safety and efficacy of Empagliflozin in Pakistani Muslim Patients with Type 2 Diabetes (SAFE-PAK); A Randomized Clinical Trial","abstract":"Abstract Background: Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitor (Empagliflozin) is an effective drug in controlling blood glucose through predominantly glycosuria. Glycosuria increases the risk of genitourinary infections in diabetes. This study was aimed to establish the safety and efficacy of Empagliflozin (Group-A) versus standard care (Group-B) in Pakistani Muslim individuals with type 2 diabetes. Methods: A multicenter, randomized clinical trial was conducted in five cities across Pakistan from July 2019 to August 2020. Patients of both genders aged 18-75 years, body mass index (BMI) ≤ 45 kg/m 2 , glycosylated hemoglobin (HbA1c) 7%-10% (53 mmol/mol to 86 mmol/mol) and treatment-naive to Empagliflozin were included. Treatment was given for 24 weeks, and allocation was done through randomization. Results : Out of 745 screened patients, 333 met the eligibility criteria, and a total of 244 (73.3%) patients were enrolled. Hypoglycemic events were significantly reported more in the standard care group, whereas positive urine culture, fungal infection, dehydration, and hypotension were insignificant between the two groups. The 6 months mean HbA1c reduction was significant in both groups; (Group-A: 0.91 ± 0.15; p<0.001 vs. Group-B2: 0.79 ± 0.14; p<0.001). Efficacy comparison at 6 months revealed a significant reduction in weight and systolic blood pressure (SBP) in Group A only (Group-A: 1.4 ± 0.4 kg; p<0.002 vs. Group-B: 0.01 ± 0.5 kg; p<1.00), (Group-A: 5.1 ± 1.7 mmHg; p<0.012 vs. Group-B: 2.3 ±1.7 mmHg; p<0.526). Conclusions: Empagliflozin was a safe drug compared to standard care in Pakistani Muslim patients with diabetes. It was as effective as standard care in the clinical setting but achieved glycemic control by reducing weight and SBP in type 2 diabetes patients. Trial Registration: This study was registered in the NIH US National Library of Medicine clinical trials registry at Clinicaltrials.gov with the registration number: NCT04665284 on 11/12/2020.","journal":"Research Square","year":2022,"id":303955,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.958,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":996812,"name":"Umar Raja","orcid":null,"position":1,"is_corresponding":false},{"id":996813,"name":"Faisal Masood Qureshi","orcid":null,"position":2,"is_corresponding":false},{"id":996372,"name":"Ali Asghar","orcid":"0000-0002-0410-7492","position":3,"is_corresponding":false},{"id":967097,"name":"Saeed Ahmed Mahar","orcid":null,"position":4,"is_corresponding":false},{"id":966683,"name":"Ibrar Ahmed","orcid":"0000-0001-8777-097X","position":5,"is_corresponding":false},{"id":966684,"name":"Tahir Ghaffar","orcid":"0000-0001-7945-2429","position":6,"is_corresponding":false},{"id":967098,"name":"Jamal Zafar","orcid":null,"position":7,"is_corresponding":false},{"id":967099,"name":"Mohammad Imtiaz Hasan","orcid":null,"position":8,"is_corresponding":false},{"id":966685,"name":"Amna Riaz","orcid":"0000-0001-7251-1502","position":9,"is_corresponding":false},{"id":966686,"name":"Syed Abbas Raza","orcid":"0000-0003-4270-7939","position":10,"is_corresponding":false},{"id":967100,"name":"Irshad Ahmed Khosa","orcid":null,"position":11,"is_corresponding":false},{"id":966687,"name":"Jahanzeb Khan","orcid":"0000-0001-6322-2979","position":12,"is_corresponding":false},{"id":966688,"name":"Jaffer Bin Baqar","orcid":"0000-0001-5256-9010","position":13,"is_corresponding":false},{"id":967094,"name":"Azizul Hasan Aamir","orcid":null,"position":0,"is_corresponding":true}],"reference_count":10,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T00:32:28.468841Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}