scholarly journals Recombinant Human Insulin in Global Diabetes Management – Focus on Clinical Efficacy

2017 ◽  
Vol 13 (01) ◽  
pp. 21 ◽  
Author(s):  
Jean Claude Mbanya ◽  
Juergen Sandow ◽  
Wolfgang Landgraf ◽  
David R Owens ◽  
◽  
...  

Biosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue. The world is experiencing an exponential rise in the prevalence of diabetes presenting an urgent need to establish effective diabetes therapy in countries burdened by inadequate health care budgets, malnutrition and infectious diseases. Recombinant human insulin has replaced animal insulins and animal-based semisynthetic human insulin thereby available in sufficient quantities and at affordable prices able to provide global access to insulin therapy. In many patients, analog insulins can offer additional clinical benefit, although at a considerably higher price thus severely restricting availability in low income countries. The approval process for recombinant human insulins (i.e. biosimilars) and analogue insulins is highly variable in the developing countries in contrast to Europe and in North America, where it is well established within a strict regulatory framework. This review aims to discuss the future access to human insulin therapy in a global context with an ever increasing burden of diabetes and significant economic implications.

2021 ◽  
Vol 17 (7) ◽  
pp. 581-588
Author(s):  
M.V. Neborachko ◽  
O.G. Phakadze

Currently, a large amount of data has been accumulated to compare recombinant human insulin with insulin analogues, including meta-analyzes of comparative efficacy and safety, as well as cost-effectiveness data and data on the possible carcinogenicity of new products. Insulin treatment is a necessity for some people with diabetes mellitus (DM) due to the need to maintain optimal blood glucose levels. The authors emphasize the need to keep in mind that new insulin drugs are much more expensive, which may limit their use. Factors such as the effectiveness of treatment, its safety, and patient satisfaction should be taken into account when deciding on the choice of therapy, but the cost of treatment cannot be ignored, given that it is usually reimbursable from the budget. In this regard, insulin therapy should be individually selected taking into account the needs of patients, treatment goals, safety, and cost. The authors propose an analysis of these data on the feasibility of using insulin analogues in comparison with recombinant human insulin for patients with type 1 diabetes and patients with type 2 diabetes and their effectiveness in both types of diabetes. A reasonable policy for the use of insulin therapy should be developed based on available clinical data based on comparative studies in different groups of diabetics and comprehensive analysis of economic data. The feasibility of a new drug should be evaluated and regularly reviewed in light of the practical results of its use in clinical practice. It is also necessary to regularly conduct a retrospective economic analysis to assess the pharmacoeconomic benefits. All of these steps should assist decision-makers and regulators in implementing effective national programs to develop new effective insulin procurement systems.


2019 ◽  
Vol 11 (7) ◽  
pp. 2164 ◽  
Author(s):  
Mathis Wackernagel ◽  
David Lin ◽  
Mikel Evans ◽  
Laurel Hanscom ◽  
Peter Raven

Mainstream competitiveness and international development analyses pay little attention to the significance of a country’s resource security for its economic performance. This paper challenges this neglect, examining the economic implications of countries resource dynamics, particularly for low-income countries. It explores typologies of resource patterns in the context of those countries’ economic prospects. To begin, the paper explains why it uses Ecological Footprint and biocapacity accounting for its analysis. Data used for the analysis stem from Global Footprint Network’s 2018 edition of its National Footprint and Biocapacity Accounts. Ranging from 1961 to 2014, these accounts are computed from UN data sets. The accounts track, year by year, how much biologically productive space is occupied by people’s consumption and compare this with how much productive space is available. Both demand and availability are expressed in productivity-adjusted hectares, called global hectares. Using this biophysical accounting perspective, the paper predicts countries’ future socio-economic performance. This analysis is then contrasted with a financial assessment of those countries. The juxtaposition reveals a paradox: Financial assessments seem to contradict assessments based on biophysical trends. The paper offers a way to reconcile this paradox, which also elevates the significance of biophysical country assessments for shaping successful economic policies.


2021 ◽  
Vol 24 (2) ◽  
pp. 205-220
Author(s):  
Zi Wen Vivien Wong ◽  
Fanyu Chen ◽  
Thian Hee Yiew

Sluggish growth in low-income countries, despite the high performance in other economic indicators, motivates the literature to switch attention to institutions. Despite its crucial economic implications, there is limited attention on rent-seeking as a driver of economic growth in low-income countries. This paper investigates the effect of rent-seeking on growth in low-income countries from 2004 to 2017using the system generalized method of moments estimator. The empirical results reveal that rent-seeking negatively affects growth, implying that it obstructs the pace of economic development in low-income countries. Hence, it is necessary for policymakers in these countries to adopt anti-rent-seeking policies to promote a rapid and sustainable growth.


2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Edoardo Mannucci

Despite the availability of many other agents, insulin is widely used as a treatment for type 2 diabetes. In vitro, insulin stimulates the growth of cancer cells, through the interaction with insulin-like growth factor-1 (IGF-1) receptors and its own receptors. In observational surveys on type 2 diabetes, insulin therapy is associated with an increased incidence of several forms of cancer, although it is difficult to discriminate the effect of confounders from that of insulin itself. Randomized trials do not confirm the increased risk associated with insulin therapy, although they do not allow to rule out some negative effects on specific forms of cancer, at least at higher doses. Among insulin analogues, glargine has a higher affinity for the IGF-1 receptor and a greater mitogenic potency in vitro than human insulin, but it is extensively metabolized in vitro to products with low IGF-1 receptor affinity. Overall, epidemiological studies suggest a possible increase of risk with glargine, with respect to human insulin, only at high doses and for some forms of cancer (i.e., breast). Data from clinical trials do not confirm, but are still insufficient to totally exclude, such increased risk. However, beneficial effects of insulin outweigh potential cancer risks.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Yin Yin Siew ◽  
Wei Zhang

AbstractThe Global Diabetes Compact was launched by the World Health Organization in April 2021 with one of its important goals to increase the accessibility and affordability of life-saving medicine—insulin. The rising prevalence of diabetes worldwide is bound to escalate the demand for recombinant insulin therapeutics, and currently, the majority of recombinant insulin therapeutics are produced from E. coli inclusion bodies. Here, a comprehensive review of downstream processing of recombinant human insulin/analogue production from E. coli inclusion bodies is presented. All the critical aspects of downstream processing, starting from proinsulin recovery from inclusion bodies, inclusion body washing, inclusion body solubilization and oxidative sulfitolysis, cyanogen bromide cleavage, buffer exchange, purification by chromatography, pH precipitation and zinc crystallization methods, proinsulin refolding, enzymatic cleavage, and formulation, are explained in this review. Pertinent examples are summarized and the practical aspects of integrating every procedure into a multimodal purification scheme are critically discussed. In the face of increasing global demand for insulin product, there is a pressing need to develop a more efficient and economical production process. The information presented would be insightful to all the manufacturers and stakeholders for the production of human insulins, insulin analogues or biosimilars, as they strive to make further progresses in therapeutic recombinant insulin development and production.


2014 ◽  
Vol 17 (4) ◽  
pp. 108-119
Author(s):  
Ivan Ivanovich Dedov ◽  
Marina Vladimirovna Shestakova

Achievement of glycemic control is the major therapeutic aim to prevent or delay the onset and progression of diabetes related complications. Insulin therapy represents a cornerstone in the treatment of diabetes and has been used widely for achieving glycemic goals. The aim for insulin therapy is to mimic the physiological profile of insulin secretion seen in nondiabetic patients. Development of the insulin analogs has offered new opportunities in the diabetes management to achieve greater safety and tolerability of diabetes treatment. Insulin degludec/insulin aspart(IDegAsp) (Ryzodeg?, Novo Nordisk, Denmark) is the first soluble co-formulation of 70% ultra-long acting insulin degludec and 30% rapid-acting prandial insulin aspart, providing both basal insulin coverage and a prandial insulin bolus in a single injection. This review discusses data regarding the efficacy, safety, tolerability and clinical benefits of IDegAsp. According to the clinical development program IDegAspprovides an achievement of similar glycemic control with superiority in lowering FPG with using less number of injections and lower daily insulin dose, and also associated with numerically lower rates of confirmed and nocturnal confirmed hypoglycaemia in comparison with premixed or basal insulin analogues, as well as a basal component for basal?bolus therapy with supplementary mealtime insulin aspart.Trial results suggest that IDegAspQD or BID maybe an appropriate and reasonable option for initiating insulin therapy in type 1 and type 2 diabetic patients inadequately controlled on maximal doses of oral antidiabetic drugs,and also a simple alternative to basal?bolus treatment in patients who require intensification of insulin therapy, especially when adherence to more complex regimens is challenging.


2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Pragya Tiwari

Diabetes highlights a growing epidemic imposing serious social economic crisis to the countries around the globe. Despite scientific breakthroughs, better healthcare facilities, and improved literacy rate, the disease continues to burden several sections, especially middle and low income countries. The present trends indicate the rise in premature death, posing a major threat to global development. Scientific and technological advances have witnessed the development of newer generation of drugs like sulphonylureas, biguanides, alpha glucosidase inhibitors, and thiazolidinediones with significant efficacy in reducing hyperglycemia. Recent approaches in drug discovery have contributed to the development of new class of therapeutics like Incretin mimetics, Amylin analogues, GIP analogs, Peroxisome proliferator activated receptors, and dipeptidyl peptidase-4 inhibitor as targets for potential drugs in diabetes treatment. Subsequently, the identification and clinical investigation of bioactive substances from plants have revolutionized the research on drug discovery and lead identification for diabetes management. With a focus on the emerging trends, the review article explores the current statistical prevalence of the disease, discussing the benefits and limitations of the commercially available drugs. Additionally, the critical areas in clinical diabetology are discussed, with respect to prospects of statins, nanotechnology, and stem cell technology as next generation therapeutics and why the herbal formulations are consistently popular choice for diabetes medication and management.


Author(s):  
Frank Agyire-Tettey ◽  
Derek Asuman ◽  
Charles Godfred Ackah ◽  
Antoinette Tsiboe-Darko

Abstract Early childhood deprivations and inequalities have social and economic implications in adulthood and thus, their elimination is essential for child development. However, child-level estimates of poverty are rare in low income countries. Using data from two recent rounds of the Ghana Demographic and Health Survey, we measure the extent and sources of childhood deprivations in Ghana and examine subgroup differentials in child poverty. In addition, we examine the child quality-quantity by estimating the causal relationship between number of children and child poverty. Finally, we assess the sources of rural-urban inequalities in child poverty. We find that despite declining incidence and intensity of multidimensional child poverty, significant subgroup differentials persist in Ghana. The findings of the paper reveal that living standards is the main contributor to multidimensional poverty in early childhood in Ghana. Our findings also confirm a significant causal relationship between child quality and quantity in Ghana, there exist a positive relationship between the number of children and the intensity of child poverty in Ghana. Finally, we find that rural-urban inequalities in child multidimensional poverty in Ghana are attributable to differences in observed maternal and household characteristics between rural and urban areas. The persistence of subgroup disparities in child poverty may be detrimental to achieving equitable and inclusive growth in the country. There is the need for considerations of equity, fairness and social justice in the distribution and development of social services and economic infrastructure to ensure even distribution of social and economic opportunities and promote social mobility across groups.


2013 ◽  
Vol 16 (1) ◽  
pp. 52-56
Author(s):  
Elena Viktorovna Surkova

Body weight (BW) excess is a characteristic problem for type 2 diabetes mellitus (T2DM) both as its pathogenetic feature and as a side effect of blood glucose lowering therapy. In the latter case reduction of glycosuria and frequent hypoglycemic events are primarily blamed for BW gain, but additional factors like direct effect of insulin on lipogenesis and influence of its supraphysiologic levels on regulation of appetite via CNS structures are also under discussion.Advances of the last years have brought new hope due to introduction of drug classes that do not affect BW. However, fraction of patients dependent on exogenous insulin shows stable trend for growth. Deterioration of beta-cell secretory capacity makes insulin an ultimately indispensable tool in the foreseeable future. As so, insulin therapy modalities with minimal impact on BW are preferable. In this regard human insulin analogues of both rapid and prolonged action have certain advantages.Current article addresses influence of pre-mixed insulin preparation NovoMix 30 (Novo Nordisk, Denmark) on BW. A summary of several studies of substantial duration (up to 3 years) suggests a neutral effect on BW in various categories of T2DM patients (including obese and elder patients).Therapy with pre-mixed preparations is an adequately safe and effective T2DM treatment modality and is advantageous for patients in whom BW gain is particularly unfavorable.


2012 ◽  
Vol 153 (40) ◽  
pp. 1589-1593 ◽  
Author(s):  
László Deák

The development of insulin therapy has not been stopped since the manufacturing of human insulin, because better mimic of physiological insulin response made it necessary to modify the human insulin molecule in order to create rapidly absorbing insulin analogues and 24-hour acting basal insulin analogues. Clinical observations indicate that the complete switch from human basal-bolus therapy to insulin analogues means not only “unit-for-unit” switch but it represents a transfer to an insulin therapy with different basal/bolus ratio as a result of different pharmacokinetic and pharmacodynamic properties of insulin and the level of insulin resistance of the patient. With reference to a case-history, the author presents his experience on a switch from human insulin to insulin analogue. Furthermore, the author summarizes data obtained from a few cases reported in international literature which draw the attention to the fact that the basal/bolus ratio should be adjusted individually, which may be the key for the success in the therapy in these cases. Orv. Hetil., 2012, 153, 1589–1593.


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