Management of Type 2 diabetes in Ramadan: Low-ratio premix insulin working group practical advice.

The challenge of insulin use during Ramadan could be minimized, if people with diabetes are metabolically stable and are provided with structured education for at least 2-3 months pre-Ramadan. Although, American diabetes association (ADA) recommendations 2010 and South Asian Consensus Guideline 2012 deal with management of diabetes in Ramadan and changes in insulin dosage, no specific guidance on widely prescribed low-ratio premix insulin is currently available. Hence, the working group for insulin therapy in Ramadan, after collective analysis, evaluation, and opinion from clinical practice, have formulated a practical advice to empower physicians with pre-Ramadan preparation, dose adjustment, and treatment algorithm for self-titration of low-ratio premix insulin.

Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice.

Background: The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir.

Methods: The present 24-week observational study of insulin initiation included 17 374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.

Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: a sub-analysis of data from the Study of Once daily LeVEmir (SOLVE).

Objectives: Older patients are particularly vulnerable to hypoglycaemia. The aim of this study was to evaluate the response to initiation of once-daily insulin detemir in patients aged ≥75 years with type 2 diabetes mellitus (T2DM) treated with one or more oral antidiabetic drugs (OADs).

Methods: A sub-analysis was conducted using data from SOLVE (Study of Once daily LeVEmir), a 24-week observational study involving 3,219 investigators and 2,817 project sites from ten countries.

Predictors of postprandial blood glucose response to biphasic insulin analogue therapy.

Biphasic insulin aspart 30 (BIAsp 30) has been shown in randomised controlled trials and the IMPROVE™ observational study to reduce postprandial blood glucose (PPBG) - thought to be an independent risk factor for cardiovascular disease. We used multivariate regression analysis to identify predictors of PPBG reduction in the IMPROVE™ study. A total of 52,419 type 2 diabetes patients were enrolled in the IMPROVE™ study (pre-study therapy subgroups: no pharmaceutical therapy, n = 8966; oral antidiabetic drugs [OADs] only, n = 33,797; insulin ± OADs, n = 9568; missing information on pre-study therapy, n = 88).

Insulin use in elderly adults: risk of hypoglycemia and strategies for care.

Hypoglycemia is a significant problem in elderly adults with diabetes mellitus. Elderly individuals with diabetes mellitus are at greater risk than younger adults for hypoglycemic events. Several factors contribute to this risk, including the high prevalence of comorbidities, polypharmacy, cognitive impairment, and concomitant use of agents that interfere with glucose metabolism.

The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries.

Aims: Evaluate the safety and efficacy of once-daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs).

Methods: This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control were recorded before and 24 weeks following insulin initiation while patients continued routine clinical management.

Ten years of experience with biphasic insulin aspart 30: from drug development to the latest clinical findings.

Biphasic insulin aspart 30 (BIAsp 30) includes 30% soluble rapid-acting insulin aspart (IAsp) along with an intermediate-acting 70% protaminated IAsp that provides coverage of prandial and basal insulin in a single injection. As BIAsp 30 has been available internationally for 10 years, this review provides a comprehensive overview of the discovery of BIAsp 30, its pharmacokinetic and pharmacodynamic profile, safety and efficacy outcomes from the clinical trial programme, 'real-life' clinical insights provided by observational study data, and cost effectiveness and quality-of-life information. These studies have demonstrated that BIAsp 30 once or twice daily is an appropriate option for insulin initiation.

Insulin analogues: how observational studies provide key insights into management of patients with type 2 diabetes mellitus.

Objective: The aim of this commentary was to evaluate the current evidence regarding the use of synthetic insulin analogues in the 'real-world' clinic setting for the treatment of type 2 diabetes mellitus (T2DM).

Methods: Relevant publications were searched on PubMed MEDLINE, EMBASE, Cochrane Register of Controlled Trials Google Scholar, NLM Gateway, Science Direct, Web of Science and OVID for the period of January 2007 to June 2010. Articles were included if they (a) provided specific study results on the use of insulin analogues in T2DM and (b) gave sufficiently clear methodology details to establish treatment strategies, diagnosis and diagnostic criteria using an observational study (OS) design.

Intensifying existing premix therapy (BIAsp 30) with BIAsp 50 and BIAsp 70: A consensus statement.

In 2009, consensus guidelines were published on intensification of insulin therapy using the premix analog biphasic insulin aspart (BIAsp) 30 in the treatment of type 2 diabetes, based on the recommendations of an international, independent expert panel. The guidelines included recommendations and titration algorithms for intensification from basal insulin once (OD) or twice daily (BID) to BIAsp 30 BID, from OD BIAsp 30 to BID, and from BID BIAsp 30 to three times daily (TID). Building on these recommendations, the objective was to develop similar, simple and effective guidelines for intensification switch from a BIAsp 30 to a mid-/high-ratio premix regimen for the vast majority of patients with type 2 diabetes.

Impact of weight gain on outcomes in type 2 diabetes.

Background: The majority of patients with type 2 diabetes mellitus (T2DM) are overweight or obese. Obesity is a significant risk factor for increased morbidity and mortality in people with T2DM, and increased weight has been shown to worsen glycemic control and increase the risk of diabetes progression.

Methods: A search was conducted of the National Library of Medicine (PubMed) for articles published from 1990 to 2009 about the treatments of T2DM, relationship between T2DM and weight gain, obesity-related comorbidities of T2DM, and T2DM therapies associated with increased weight.

Declining incidence of imported malaria in the Netherlands, 2000-2007.

Background: To describe the epidemiology and trends of imported malaria in the Netherlands from 2000 through 2007.

Methods: Based on national surveillance data regarding all reported infections of imported malaria, diagnosed 2000 through 2007, incidence and trends of imported malaria in the Netherlands were estimated. Travellers statistics were used to estimate incidence, and data on malaria chemoprophylaxis prescriptions were used to estimate the number of unprotected travellers.

A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study.

Objective: To compare efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) with insulin (glargine) in type 2 diabetic patients who were not maintaining glycemic control on basal insulin and oral antidiabetic drugs.

Methods: In a 24-week, open-label, parallel-group trial, type 2 diabetic patients who were not maintaining glycemic control on basal insulin (glargine or neutral protamine Hagedorn) + oral antidiabetic drugs were randomly assigned to twice-daily BIAsp 30 + metformin or once-daily glargine + metformin + secretagogues (secretagogues were discontinued in the BIAsp 30 arm).

Results: One hundred thirty-seven patients were randomly assigned to the BIAsp 30 group and 143 patients were randomly assigned to the glargine group.

Practical guidance to insulin management.

The practical guidance to insulin management is a simple tool for health care providers, particularly primary care physicians (PCPs). Developed by experts in diabetes care at an international meeting, it aims to help physicians make key decisions to optimize insulin management and decrease long-term morbidity risk. With a growing role for PCPs in type 2 diabetes, the practical guidance focuses on confident, appropriate and timely insulin initiation.

Mid- and high-ratio premix insulin analogues: potential treatment options for patients with type 2 diabetes in need of greater postprandial blood glucose control.

Some patients with type 2 diabetes continue to have high postprandial blood glucose levels on twice-daily regimens of 'low-ratio' premix insulin formulations (up to 30% rapid-acting, with 70% protracted insulin). These patients require intensified insulin therapy, which can be provided by a twice- or thrice-daily regimen of mid-ratio (50% rapid-acting and 50% protaminated intermediate-acting insulin - human or analogue) or high-ratio (70% rapid-acting and 30% protaminated insulin - analogue only) premix insulin. Alternatively, a third daily injection of low-ratio premix insulin can be added to the regimen, with the option of incorporating one or more injections of mid- or high-ratio premix as required, and as an alternative to basal-bolus therapy.

Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: a meta-analysis.

Background: Insulin is recommended as a second-line treatment after diet and metformin fail to reach and/or maintain glycemic targets considered to minimize the risk for long-term diabetic complications. Hypoglycemia and the fear of developing hypoglyce-mia, however, remain substantial barriers to the initiation and optimal use of insulin.

Objective: The aim of this study was to compare biphasic insulin aspart 30 (BIAsp 30) with biphasic human insulin 30 (BHI 30) with respect to glycemic control and the risk for hypoglycemia using a meta-analysis of clinical trials comparing these insulins in patients with type 2 diabetes mellitus (T2DM).

Practical guidance on intensification of insulin therapy with BIAsp 30: a consensus statement.

Background: Basal insulin and premix insulin are commonly prescribed first-line insulin therapies for patients failing to maintain glycaemic control on oral therapy. When control on these insulins starts to drift, premix analogues, such as biphasic insulin aspart 30/70 (BIAsp 30), are a simple and effective tool for intensification as they can be injected up to three-times daily (TID). However, at present, international recommendations for intensification of insulin therapy using premix analogues are limited and specific guidance on dosing is not available for many scenarios.

Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study.

Aims: The international IMPROVE observational study investigated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in the routine treatment of patients with type 2 diabetes. We present analyses for the subgroup of patients who switched from basal insulin to BIAsp 30.

Methods: Patients in routine care who started insulin therapy with or switched to BIAsp 30 from existing insulin regimens were eligible for this 26-week study.

Self-titration of biphasic insulin aspart 30/70 improves glycaemic control and allows easy intensification in a Dutch clinical practice.

Aims: This 18-month study assessed the improvement in glycaemic control and proportion of patients reaching glycated haemoglobin (HbA(1c)) targets with biphasic insulin aspart 30/70 (BIAsp 30) in clinical practice.

Methods: Type-2 diabetes patients failing on oral antidiabetic drugs (n=90) or existing insulin regimens (n=59) started or switched to BIAsp 30. Thiazolidinediones were stopped, metformin was continued.

Intensification lessons with modern premixes: from clinical trial to clinical practice.

This paper aims to underscore the importance of insulin intensification, while highlighting the clinical utility of modern premixes through intensification lessons, by utilising data from key clinical trials, and from the recently published large observational PRESENT Study. Insulin intensification is any change made to an initial insulin regimen to improve glycaemic control. Yet, despite established glycaemic targets, current HbA1c levels in insulin-treated patients suggest that 'real-world' insulin regimens are not optimally intensified.

Initiating insulin in primary care--the role of modern premixed formulations.

Starting insulin therapy earlier can help reduce the risk of micro- and macrovascular complications associated with the progression of type 2 diabetes mellitus (T2DM). However, barriers to the initiation of insulin have been identified. Premixed insulins offer a simpler regimen than basal-bolus therapy for T2DM.

Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes.

Aim: This trial evaluated the potential for improving glycaemic control by intensifying a conventional twice-daily therapy with premixed human insulin (HI) to a thrice-daily regimen using premixed formulations of biphasic insulin aspart (BIAsp) in patients with type 1 or type 2 diabetes.

Methods: This was a multicentre, open-label, parallel group trial. After a 4-week run-in period, patients were randomized 1 : 1 to 16 weeks of treatment.

Importance of observational studies in clinical practice.

Background: In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational-study methods and advances in statistical analysis.

Objective: This article reviews the current literature and reports some of the key studies indicating that observational studies can both complement and build on the evidence base established by randomized controlled trials (RCTs).

Importance of observational studies in clinical practice.

Background: In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational-study methods and advances in statistical analysis.

Objective: This article reviews the current literature and reports some of the key studies indicating that observational studies can both complement and build on the evidence base established by randomized controlled trials (RCTs).

Factors determining use of pre-travel preventive health services by West African immigrants in The Netherlands.

Objective: To determine for what reasons West African immigrants, who contribute the largest single group of malaria cases in the Netherlands, visit pre-travel preventive health services and whether use of such services is likely to improve use of preventive measures.

Methods: Semi-structured interviews with eligible participants recruited through West African churches and societies and at a large festival.

Results: A total of 70% of the total non-random sample of 292 participants said that they always use pre-travel preventive health services before travelling.