Safety and efficacy of Empagliflozin in Pakistani Muslim patients with type 2 diabetes (SAFE-PAK); a randomized clinical trial.

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/m2, 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. More hypoglycemic events were reported in the standard care group, whereas positive urine culture, fungal infection, dehydration, and hypotension occurrence were comparable 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.

Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study.

BACKGROUND: Management of diabetes during fasting is a clinical challenge. Sodium glucose co-transporter -2 inhibitors (SGLT2i) are considered safe with a low risk of hypoglycemia. However, studies on SGLT2i are scarce. This study was designed to compare the efficacy, safety, and tolerability of empagliflozin with metformin during Ramadan in comparison with sitagliptin and metformin. METHODS: It was a prospective, observational study, conducted at 11 different sites all across Pakistan on an outpatient basis during Ramadan (May 2021-June 2021). including 132 patients, 88 who received metformin and sitagliptin, and 44 patients who received metformin and empagliflozin. RESULTS: Patients of the SGLT-2i group experienced similar symptomatic hypoglycemic episodes (15.9%) as the sitagliptin group. There was an improvement in blood sugar levels after the use of SGLT-2i (RBS 181 ± 64 before Ramadan vs 162 ± 53 after Ramadan). HbA1c also improved after the use of SGLT-2i before and after Ramadan (7.2 ± 0.8 vs 6.9 ± 0.9 for Metformin + Empagliflozin and 7.8 ± 1.5 vs 7.6 ± 1.6 for Metformin and sitagliptin). Weight and BMI improved after the use of SGLT-2i (BMI 36.5 ± 4.8 before Ramadan and 33.7 ± 2.4 after Ramadan). There were no reported cases of urinary tract infection in the empagliflozin group. CONCLUSION: SGLT-2 inhibitors combined with metformin for patients with diabetes during Ramadan fasting is as effective, safe and well tolerated as DPP4 combined with metformin.

Dapagliflozin: The outcome of use as add-on therapy in real-life clinical setting -An Audit.

OBJECTIVE: Dapagliflozin is the first novel sodium glucose co transporter 2 inhibitor for the treatment of Type 2 diabetes. The aim of this audit was to evaluate its effectiveness and safety in a real-life clinical setting. METHODS: We analyze data from four UK district general hospitals on patients initiated on dapagliflozin. HbA1c, weight and daily insulin dosage was recorded at baseline and 6 months follow-up. RESULTS: At baseline, mean HbA1c was 82±19.21mmol/mol(9.7%) and mean weight was 102±18.1kg. The average reduction in HbA1c at 6 months was 13±7.23 mmol/mol (1%) whereas the average reduction in weight was 2 ±2.02 kg.. A mean reduction in daily insulin requirement by 12±8.3 units at 6 months compared to baseline was noted. There were certain complications in patients taking insulin and gliclazide including candidiasis, urinary tract infection and hypoglycaemia, and 4% patients discontinued dapagliflozin due to side effects. CONCLUSIONS: Our results confirm that dapagliflozin can be used safely and effectively in a real-life setting.

Essential diagnostics and devices in primary care diabetes.

Medication is essential for diabetes care, and this is reflected in the Essential Medicines lists prepared by the World Health Organization and various countries. The need for essential diagnostics, and essential devices, however, has not been addressed adequately. In this communication, we call for creating a list of the essential diagnostics and devices that are required in primary and secondary/ tertiary diabetes care. We hope that this will encourage policymakers and clinicians to work together, to ensure that these are made available, accessible, and affordable for all patients.

Efficacy and Safety of Dulaglutide in Type 2 Diabetes Patients in Endocrinology Clinics of Islamabad, Pakistan.

Objective: Our objective was to ascertain the efficacy and safety of once weekly Dulaglutide among patients with Type 2 diabetes of Pakistani origin. Methods: This prospective cohort study was conducted at the Endocrinology Clinics of Shifa International Hospital, Islamabad and Umar Diabetes and Foot Care Centre, Islamabad, Pakistan during the period from July 2020 to December 2020. Dulaglutide at the dose of 1.5 mg once weekly was initiated in patients with BMI >28 and suboptimal glucose control in the background of Type 2 Diabetes who were also taking one or more of oral anti-diabetic and/or insulin therapy. Results: Mean age of patient cohort (n = 148) was 49.51 years (SD +/- 12.15) with 53.5% (n = 85) having type 2 diabetes for a duration of over 10 years. Mean weight was 93.2 kg at baseline with end of study mean weight being 90.7 kg. Mean HbA1c at baseline was 9.2%, which improved to 8.05% at the end of study. The main side-effects were nausea in 32%, vomiting in 8%, and diarrhea in 7% with 19% discontinuation rate due to cost and side-effects. Conclusion: Dulaglutide as a therapy demonstrated favorable HbA1c and weight reduction in obese type 2 diabetes patients of Pakistani origin.