Wan Mohamad Wan Bebakar

Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT

Abstract Objectives: To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs. Research design and methods: In this 26-week, open-labeled, randomized, parallel-group, multinational, treat-to-target trial, 480 insulin-naïve subjects were randomized to receive either BIAsp 30 before dinner or insulin glargine at bedtime, both in combination with metformin and glimepiride. Trial registration: NCT00469092, ClinicalTrials.gov. Results: A total of 433 subjects completed the trial. Estimated mean reduction in HbA1c from baseline to end of treatment was −1.41% with BIAsp 30 and −1.25% with insulin glargine (BIAsp 30 – insulin glargine = −0.16%, 95% CI [−0.30; −0.02], p = 0.029). At the end of treatment, mean HbA1c was 7.1% and 7.3% for BIAsp 30 and insulin glargine, respectively. Significantly lower plasma glucose levels were observed with BIAsp 30 post-dinner (BIAsp 30 – insulin glargine = −0.52 mmol/L, 95% CI [−1.02; −0.03], p = 0.04) and at bedtime (BIAsp 30 – insulin glargine = −0.78 mmol/L, 95% CI [−1.25; −0.31], p < 0.01). The relative risk (RR) of experiencing a nocturnal hypoglycemic episode (00:00–06.00 a.m.) was significantly higher with BIAsp 30 than with insulin glargine (1.1 versus 0.5 episodes/year, RR = 2.41, 95% CI [1.34; 4.34], p = 0.003), but overall hypoglycemia rates were low. There were three major hypoglycemic episodes in each group. Conclusions: With respect to HbA1c, BIAsp 30 fulfilled the statistical criteria for non-inferiority and superiority to insulin glargine and, according to pre-defined criteria, the improvements in HbA1c are considered clinically equivalent. Subjects had an increased risk of minor nocturnal hypoglycemia with BIAsp 30. There were no differences in treatment satisfaction between the two groups.

Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes

Aim:  To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix® 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy.

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.

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.

Prevalence of Abnormal Glucose Tolerance and Risk Factors in Urban and Rural Malaysia

OBJECTIVE To determine the prevalence of prediabetes and diabetes among rural and urban Malaysians. RESEARCH DESIGN AND METHODS This cross-sectional survey was conducted among 3,879 Malaysian adults (1,335 men and 2,544 women). All subjects underwent the 75-g oral glucose tolerance test (OGTT). RESULTS The overall prevalence of prediabetes was 22.1% (30.2% in men and 69.8% in women). Isolated impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) were found in 3.4 and 16.1% of the study population, respectively, whereas 2.6% of the subjects had both IFG and IGT. Based on an OGTT, the prevalence of newly diagnosed type 2 diabetes was 12.6% (31.0% in men and 69.0% in women). The prediabetic subjects also had an increased prevalence of cardiovascular disease risk factors. CONCLUSIONS The large proportion of undiagnosed cases of prediabetes and diabetes reflects the lack of public awareness of the disease.

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.

Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(®) : SIMPLE USE).

To compare the efficacy and safety of two titration algorithms for insulin degludec/insulin aspart (IDegAsp) administered once daily with metformin in participants with insulin‐naïve Type 2 diabetes mellitus.

Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial

Compare effects of liraglutide 1.8 mg and sulphonylurea, both combined with metformin, on glycaemic control in patients with type 2 diabetes (T2D) fasting during Ramadan.

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.

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.