Hypoglycemia awareness among insulin-treated patients with diabetes in Malaysia: A cohort subanalysis of the HAT study.

AIMS: The present Malaysian cohort analysis determined the prevalence of hypoglycemia among patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) attending primary care- or hospital-based diabetes clinics in Malaysia and their awareness of the symptoms of hypoglycemia. METHODS: The Hypoglycemia Assessment Tool (HAT) study was a non-interventional, 6-month retrospective and 4-week prospective analysis of hypoglycemic events in 24 countries, using self-assessment questionnaires and diaries among patients with T1DM/T2DM aged ≥18years, using insulin for >12months. This report focuses on prospective data, as they are less prone to recall bias. RESULTS: There were 1153 participants in the Malaysian cohort (114 T1DM; 1039 T2DM). In the prospective period, 50.4% and 33.4% of patients reported ≥1 hypoglycemic events, with estimated rates of 20.3 and 13.1 events per patient-year of exposure in patients with T1DM and T2DM, respectively. 24.8% and 16.1% of patients with T1DM or T2DM, respectively, reported ≥1 nocturnal hypoglycemic event. The majority of patients (96.5%, T1DM; 91.8%, T2DM) knew what hypoglycemia was prior to the study. Impaired awareness was present in 48.0% (T1DM) and 36.9% (T2DM) of patients. In the prospective period, 50% of patients with T1DM or T2DM consulted a doctor or nurse following a hypoglycemia episode. CONCLUSIONS: Half of patients with T1DM and a third of patients with T2DM reported ≥1 hypoglycemic event during the prospective period. Although the majority of patients knew the typical features of hypoglycemia, many reported impaired ability to recognize symptoms in real life. The present findings highlight the importance of patient education and physician awareness in dealing with hypoglycemia, in particular the burden of hypoglycemic unawareness. CLINICAL TRIAL NUMBER: This trial was registered at www.clinicaltrials.gov as NCT01696266 on 26 September 2012.

Diabetes and Ramadan: Practical guidelines.

Ramadan fasting is one of the five pillars of Islam and is compulsory for all healthy Muslims from puberty onwards. Exemptions exist for people with serious medical conditions, including many with diabetes, but a large number will participate, often against medical advice. Ensuring the optimal care of these patients during Ramadan is crucial. The International Diabetes Federation (IDF) and Diabetes and Ramadan (DAR) International Alliance have come together to deliver comprehensive guidelines on this subject. The key areas covered include epidemiology, the physiology of fasting, risk stratification, nutrition advice and medication adjustment. The IDF-DAR Practical Guidelines should enhance knowledge surrounding the issue of diabetes and Ramadan fasting, thereby empowering healthcare professionals to give the most up-to-date advice and the best possible support to their patients during Ramadan.

TREATMENT INTENSIFICATION WITH INSULIN DEGLUDEC/INSULIN ASPART TWICE DAILY: RANDOMIZED STUDY TO COMPARE SIMPLE AND STEP-WISE TITRATION ALGORITHMS.

OBJECTIVE: This 26-week, multicenter, randomized, open-label, parallel-group, treat-to-target trial in adults with type 2 diabetes compared the efficacy and safety of treatment intensification algorithms with twice-daily (BID) insulin degludec/insulin aspart (IDegAsp). METHODS: Patients randomized 1:1 to IDegAsp BID used either a 'Simple' algorithm (twice-weekly dose adjustments based on a single prebreakfast and pre-evening meal self-monitored plasma glucose [SMPG] measurement; IDegAsp[BIDSimple], n = 136) or a 'Stepwise' algorithm (once-weekly dose adjustments based on the lowest of 3 pre-breakfast and 3 pre-evening meal SMPG values; IDegAsp[BIDStep-wise], n = 136). RESULTS: After 26 weeks, mean change from baseline in glycated hemoglobin (HbA1c) with IDegAsp[BIDSimple] was noninferior to IDegAsp[BIDStep-wise] (-15 mmol/mol versus -14 mmol/mol; 95% confidence interval [CI] upper limit, <4 mmol/mol) (baseline HbA1c: 66.3 mmol/mol IDegAsp[BIDSimple] and 66.6 mmol/mol IDegAsp[BIDStep-wise]). The proportion of patients who achieved HbA1c <7.0% (<53 mmol/mol) at the end of the trial was 66.9% with IDegAsp[BIDSimple] and 62.5% with IDegAsp[BIDStep-wise]. Fasting plasma glucose levels were reduced with each titration algorithm (-1.51 mmol/L IDegAsp[BIDSimple] versus -1.95 mmol/L IDegAsp[BIDStep-wise]). Weight gain was 3.8 kg IDegAsp[BIDSimple] versus 2.6 kg IDegAsp[BIDStep-wise], and rates of overall confirmed hypoglycemia (5.16 episodes per patient-year of exposure [PYE] versus 8.93 PYE) and nocturnal confirmed hypoglycemia (0.78 PYE versus 1.33 PYE) were significantly lower with IDegAsp[BIDStep-wise] versus IDegAsp[BIDSimple]. There were no significant differences in insulin dose increments between groups. CONCLUSION: Treatment intensification with IDegAsp[BIDSimple] was noninferior to IDegAsp[BIDStep-wise]. Both titration algorithms were well tolerated; however, the more conservative step-wise algorithm led to less weight gain and fewer hypoglycemic episodes. Clinicaltrials.gov: NCT01680341.

TRADITIONAL CARDIOVASCULAR RISK-FACTORS AMONG HEALTHCARE WORKERS IN KELANTAN, MALAYSIA.

We conducted a cross sectional study of cardiovascular risk factors among healthcare workers at four government hospitals in Kelantan, Malaysia. We randomly selected 330 subjects fulfilling the following study criteria: those who had been working for at least one year at that health facility, Malaysians citizens and those with some form of direct contact with patients. We conducted an interview, obtained physical measurements, a fasting blood sugar and fasting lipid profiles among 308 subjects. The mean age of the subjects was 43.5 years, 82% were female; 30.8%, 14.3%, 10.4%, 1.3% and 1.6% of the subjects had dyslipidemia, hypertension, diabetes mellitus, a history of stroke and a history of ischemic heart disease, respectively. Forty-two percent of subjects had at least one medical condition. The mean body mass index (BMI) was 27.0 kg/M2 (SD=4.8) and 24.3% had a BMI > or =30 kg/M2. The mean systolic and diastolic blood pressures were 121.5 mmHg (SD=14.0) and 76.5 mmHg (SD=9.7), respectively and the mean waist-hip ratio was 0.84 (SD=0.1). The mean fasting blood sugar, total cholesterol, triglyceride, high density lipoprotein and low density lipoprotein were 5.8 mmol/l (SD=2.4), 5.5 mmol/l (SD=1.0), 1.4 mmol/l (SD=0.9), 1.5 mmol/l (SD=0.3) and 3.5 mmol/l (SD=0.9), respectively. Our study population had a smaller proportion of hypertension than that of the general Malaysian population. They had higher fasting total cholesterol, slightly lower fasting blood sugar, with a large proportion of them, obese and had diabetes. Immediate intervention is needed to reduce the traditional cardiovascular risk factors in this population. Keywords: cardiovascular risk factors, health care workers, Malaysia

Safety and effectiveness of insulin aspart in type 2 diabetic patients: results from the ASEAN cohort of the A1chieve study.

AIM: To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A1chieve study. METHODS: T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire. RESULTS: Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean ± SD age of 56.6 ± 11.2 years, BMI of 24.2 ± 3.9 kg/m(2) and diabetes duration of 7.0 ± 5.7 years were included. The mean daily IAsp dose was 0.51 ± 0.31 U/kg at baseline titrated up to 0.60 ± 0.29 U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5 ± 1.6% at baseline to 7.6 ± 1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8 ± 14.6 points, p < 0.001). CONCLUSIONS: Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.

Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A1chieve study.

AIM: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A1chieve study. METHODS: Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters. RESULTS: This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3 ± 10.8 years, BMI, 24.9 ± 4.6 kg/m(2) and diabetes duration, 7.5 ± 5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 ± 13.8 points, p < 0.001). CONCLUSION: BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.

Prevalence of metabolic syndrome and its risk factors in adult Malaysians: results of a nationwide survey.

Aim: To report the national prevalence of metabolic syndrome (MetS) and its risk factors among adult Malaysians (>18 years old) based on World Health Organization (WHO), the National Cholesterol Education Program Expert Panel III (ATP III), International Diabetes Federation (IDF) and the 'Harmonized' criteria.Methods: A multi-stage stratified sampling method was used to select 4341 subjects from Peninsular and East Malaysia. Subjects underwent physical and clinical examinations.Results: Based on the WHO, ATP III, IDF and Harmonized definitions, the overall crude prevalences of MetS were 32.1, 34.3, 37.1 and 42.5%, respectively. Regardless of the criteria used, MetS was higher in urban areas, in females, in the Indian population and increased significantly with age. Risk factors also increased with age; abdominal obesity was most prevalent (57.4%), was higher in females (64.2%) and was highest in Indians (68.8%).Hypertension was higher in males (56.5%) and highest among Malays (52.2%). In contrast,the Chinese had the highest prevalence of hypertriglyceridemia (47.4%).Conclusions: Malaysia has a much higher prevalence of MetS compared with other Asian countries and, unless there is immediate intervention to reduce risk factors, this may pose serious implications on the country's healthcare costs and services.

Prevalence of overweight and obesity among adult Malaysians: an update.

A total of 4428 adults (>18 years old) from 5 different selected regions in Peninsular and East Malaysia participated in this health survey. Using World Health Organization recommendations for body mass index (BMI), the prevalence of overweight and obesity were found to be 33.6% (95% CI= 32.2, 35.0) and 19.5% (95% CI= 18.3, 20.7) respectively. There were more females who were obese (22.5%, 95% CI=20.9, 24.0) compared to males (14.1%, 95% CI=12.3, 15.9). Highest prevalence of obesity were among the Indians (24.6%, 95% CI=20.3, 29.3), followed closely by the Malays (23.2%, 95% CI=21.6, 24.8%) and lowest prevalence was among the Chinese subjects (8.2%, 95% CI=6.2, 10.6). More than 43% of the 531 younger subjects (<30 years old) were either overweight (20%, 95% CI=16.6, 23.6) or obese (13.9%, 95% CI=11.1, 17.2%). All subjects who claimed to be non-diabetes were required to undergo 75 g glucose tolerance test. Compared to subjects with normal BMI (18.5-24.9 kg/m2), there was a 3- and 2-folds increase in the prevalence of newly diagnosed diabetes and impaired glucose tolerance respectively, among obese subjects (BMI>30 kg/m2) who initially claimed to have no diabetes. This study highlights a need for more active, inter-sectoral participation advocating a health-promoting environment in order to combat obesity in this country.

Prevalence of metabolic syndrome and its risk factors in adult Malaysians: results of a nationwide survey.

AIM: To report the national prevalence of metabolic syndrome (MetS) and its risk factors among adult Malaysians (>18 years old) based on World Health Organization (WHO), the National Cholesterol Education Program Expert Panel III (ATP III)(,) International Diabetes Federation (IDF) and the 'Harmonized' criteria. METHODS: A multi-stage stratified sampling method was used to select 4341 subjects from Peninsular and East Malaysia. Subjects underwent physical and clinical examinations. RESULTS: Based on the WHO, ATP III, IDF and Harmonized definitions, the overall crude prevalences of MetS were 32.1, 34.3, 37.1 and 42.5%, respectively. Regardless of the criteria used, MetS was higher in urban areas, in females, in the Indian population and increased significantly with age. Risk factors also increased with age; abdominal obesity was most prevalent (57.4%), was higher in females (64.2%) and was highest in Indians (68.8%). Hypertension was higher in males (56.5%) and highest among Malaysians (52.2%). In contrast, the Chinese had the highest prevalence of hypertriglyceridaemia (47.4%). CONCLUSIONS: Malaysia has a much higher prevalence of MetS compared with other Asian countries and, unless there is immediate intervention to reduce risk factors, this may pose serious implications on the country's healthcare costs and services.

Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs.

We compare the efficacy and safety of once-daily biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine in Asian subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs (OADs). In a 26-week, open-labelled, randomised, parallel-group, multinational, multicentre, treat-to-target trial, 155 insulin-naïve Asian subjects were treated with either BIAsp 30 or insulin glargine, both in combination with metformin and glimepiride. Change in HbA(1c) at end of treatment with BIAsp 30 was superior to insulin glargine (BIAsp 30-glargine=-0.36%, 95% CI [-0.64; -0.07], p=0.015). Mean self-measured plasma glucose (SMPG) at bedtime was significantly lower with BIAsp 30 than insulin glargine (7.98+/-0.34 mmol/L vs. 9.16+/-0.33 mmol/L, p=0.0078). Incidences of minor and daytime hypoglycaemia were higher with BIAsp 30 than those with glargine, but the difference did not reach the statistical significance. No difference was seen in nocturnal hypoglycaemia. The incidence of adverse events was comparable between treatments, with low incidence of serious adverse events and major hypoglycaemia. Mean body weight increased slightly in both groups. In insulin-naïve Asian subjects with type 2 diabetes who are inadequately controlled with OADs, once-daily BIAsp 30 is superior to insulin glargine.