Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia.

AIMS: To assess the effectiveness and safety of vildagliptin/metformin initial combination therapy in drug-naïve patients with type 2 diabetes mellitus (T2DM). METHODS: INITIAL was a 24-week prospective, observational study in T2DM patients with glycated hemoglobin (HbA1c) ≥ 7.5%, and prescribed vildagliptin/metformin as initial combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. Key secondary endpoints were HbA1c change from baseline to week 12, proportion of patients achieving HbA1c ≤7.0%, change in body weight at 12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass index [BMI], dosage strength, co-morbidities) from baseline to week 24, and safety. RESULTS: A total of 532 patients were enrolled. The mean age, HbA1c, and BMI were 49.6 ± 11.27 years, 9.3 ± 1.57%, and 26.7 ± 4.50 kg/m2, respectively. Cardiovascular risk factors present at baseline were dyslipidemia (30.1%), hypertension (29.7%), and obesity (20.9%). The mean reductions in HbA1c from baseline to week 12 (-1.6 ± 1.59%) and 24 (-1.9 ± 1.70%) were statistically significant (p < .001). At 24 weeks, 39.6% of patients achieved HbA1c ≤ 7.0%, and the mean body weight reduction was -1.1 ± 2.62 kg. HbA1c reductions were consistently seen from baseline to weeks 12 and 24 in the various sub-groups. Overall, 48 (9.0%) patients reported adverse events, including one hypoglycemic episode. There were no serious adverse events or deaths. CONCLUSIONS: Overall, in a relatively young drug-naïve T2DM Asian study population with high baseline HbA1c and often associated with cardiovascular risk factors, vildagliptin/metformin combination therapy was associated with significant and clinically relevant HbA1c reduction from baseline. This effect was seen at week 12, was maintained over 24 weeks, and was accompanied by good tolerability.

Hypoglycaemia among insulin-treated patients with Diabetes: Southeast Asia Cohort of IO HAT Study / Journal of the ASEAN Federation of Endocrine Societies

Objective@#To provide real-world data on hypoglycaemia incidence in patients with type 1 (T1D) or type 2 diabetes (T2D) from the Southeast Asian cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study.@*Methodology@#IO HAT was a non-interventional, multicentre, 6-month retrospective and 4-week prospective study of hypoglycaemic events among insulin-treated adults with T1D or T2D, including four countries in Southeast Asia (Singapore, Philippines, Indonesia, and Bangladesh). Data were collected using a two-part self-assessment questionnaire (SAQ1 for retrospective and SAQ2 for prospective). The primary endpoint was the percentage of patients experiencing at least one hypoglycaemic event during the 4-week prospective observational period (ClinicalTrials.gov Identifier: NCT02306681).@*Results@#A total of 2594 patients completed SAQ1. Nearly all patients reported experiencing any hypoglycaemic event in the 4-week prospective period (T1D, 100%; T2D, 97.3%), with all patients reporting higher rates in the prospective versus retrospective period. Severe hypoglycaemia was also reported higher prospectively (57.2% and 76.9%) than retrospectively (33.9% and 12.2%) in both T1D and T2D, respectively. Nocturnal hypoglycaemia was reported higher retrospectively than prospectively.@*Conclusion@#Incidence of any and severe hypoglycaemia in the Southeast Asian cohort of IO HAT was higher prospectively versus retrospectively, suggesting hypoglycaemia has previously been under-reported in this region.