METHOD: Type 2 diabetes mellitus patients (n = 73) attending endocrine clinic at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) were randomised to either control (n = 36) or intervention group (n = 37) after screening. Patients in the intervention group received an intervention from a pharmacist during the enrolment, after three and six months of the enrolment. Outcome measures such as HbA1c, BMI, lipid profile, Morisky scores and quality of life (QoL) scores were assessed at the enrolment and after 6 months of the study in both groups. Patients in the control group did not undergo intervention or educational module other than the standard care at UKMMC.
RESULTS: HbA1c values reduced significantly from 9.66% to 8.47% (P = 0.001) in the intervention group. However, no significant changes were noted in the control group (9.64-9.26%, P = 0.14). BMI values showed significant reduction in the intervention group (29.34-28.92 kg/m(2); P = 0.03) and lipid profiles were unchanged in both groups. Morisky adherence scores significantly increased from 5.83 to 6.77 (P = 0.02) in the intervention group; however, no significant change was observed in the control group (5.95-5.98, P = 0.85). QoL profiles produced mixed results.
CONCLUSION: This randomised controlled study provides evidence about favourable impact of a pharmacist led diabetes intervention programme on HbA1c, medication adherence and QoL scores amongst type 2 diabetes patients at UKMMC, Malaysia.
METHODS: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.
RESULTS: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.
CONCLUSION: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.
TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.