Insulin analog: Difference between revisions

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An '''insulin analog''' ([[American and British English spelling differences#-ogue, -og|also called]] an '''insulin analogue''') is any of several types of [[insulin (medication)|medical insulin]] that are altered forms of the hormone [[insulin]], different from any occurring in nature, but still available to the human body for performing the same action as human insulin in terms of [[Diabetes management#Glycemic control|controlling blood glucose levels in diabetes]]. Through [[genetic engineering]] of the underlying [[DNA]], the [[amino acid sequence]] of insulin can be changed to alter its [[ADME]] (absorption, distribution, metabolism, and excretion) characteristics. Officially, the [[U.S. Food and Drug Administration]] (FDA) refers to these agents as '''insulin receptor ligands''' (because, like insulin itself, they are [[ligand (biochemistry)|ligands]] of the [[insulin receptor]]), although they are usually just referred to as insulin analogs or even (loosely but commonly) just insulin (without further specification).

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A [[meta-analysis]] completed in 2007 and updated in 2020 of numerous [[randomized controlled trials]] by the international [[Cochrane Collaboration]] found that the effects on blood glucose and glycated haemoglobin A1c [[Glycated hemoglobin|(HbA1c)]] were comparable, treatment with [[Insulin glargine|glargine]] and [[Insulin detemir|detemir]] resulted in fewer cases of [[hypoglycemia]] when compared to [[NPH insulin]]. Treatment with detrimir also reduced the frequency of serious hypoglycemia. This review did note limitations, such as low glucose and HbA1c targets, that could limit the applicability of these findings to daily clinical practice.

In 2007, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) [https://web.archive.org/web/20080208123345/http://www.iqwig.de/index.658.en.html report], concluded that there is currently "no evidence" available of the superiority of rapid-acting insulin analogs over synthetic human insulins in the treatment of adult patients with type 1 diabetes. Many of the studies reviewed by IQWiG were either too small to be considered statistically reliable and, perhaps most significantly, none of the studies included in their widespread review were blinded, the gold-standard methodology for conducting clinical research. However, IQWiG's terms of reference explicitly disregard any issues which cannot be tested in double-blind studies, for example a comparison of radically different treatment regimes. IQWiG is regarded with skepticism by some doctors in Germany, being seen merely as a mechanism to reduce costs. But the lack of study blinding does increase the risk of bias in these studies. The reason this is important is because patients, if they know they are using a different type of insulin, might behave differently (such as testing blood glucose levels more frequently, for example), which leads to bias in the study results, rendering the results inapplicable to the diabetes population at large. Numerous studies have concluded that any increase in testing of blood glucose levels is likely to yield improvements in glycemic control, which raises questions as to whether any improvements observed in the clinical trials for insulin analogues were the result of more frequent testing or due to the drug undergoing trials.~~{{citation needed|date=May 2022}}~~

In 2007, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) [https://web.archive.org/web/20080208123345/http://www.iqwig.de/index.658.en.html report], concluded that there is currently "no evidence" available of the superiority of rapid-acting insulin analogs over synthetic human insulins in the treatment of adult patients with type 1 diabetes. Many of the studies reviewed by IQWiG were either too small to be considered statistically reliable and, perhaps most significantly, none of the studies included in their widespread review were blinded, the gold-standard methodology for conducting clinical research. However, IQWiG's terms of reference explicitly disregard any issues which cannot be tested in double-blind studies, for example a comparison of radically different treatment regimes. IQWiG is regarded with skepticism by some doctors in Germany, being seen merely as a mechanism to reduce costs. But the lack of study blinding does increase the risk of bias in these studies. The reason this is important is because patients, if they know they are using a different type of insulin, might behave differently (such as testing blood glucose levels more frequently, for example), which leads to bias in the study results, rendering the results inapplicable to the diabetes population at large. Numerous studies have concluded that any increase in testing of blood glucose levels is likely to yield improvements in glycemic control, which raises questions as to whether any improvements observed in the clinical trials for insulin analogues were the result of more frequent testing or due to the drug undergoing trials.

In 2008, the [[Canadian Agency for Drugs and Technologies in Health]] (CADTH) found, in its comparison of the effects of insulin analogues and biosynthetic human insulin, that insulin analogues failed to show any clinically relevant differences, both in terms of glycemic control and adverse reaction profile.

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[[Category:Peptide hormones]]

[[Category:Peptide therapeutics]]

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 {{short description|Synthetic forms of insulin protein}}
 An '''insulin analog''' ([[American and British English spelling differences#-ogue, -og|also called]] an '''insulin analogue''') is any of several types of [[insulin (medication)|medical insulin]] that are altered forms of the hormone [[insulin]], different from any occurring in nature, but still available to the human body for performing the same action as human insulin in terms of [[Diabetes management#Glycemic control|controlling blood glucose levels in diabetes]]. Through [[genetic engineering]] of the underlying [[DNA]], the [[amino acid sequence]] of insulin can be changed to alter its [[ADME]] (absorption, distribution, metabolism, and excretion) characteristics.  Officially, the [[U.S. Food and Drug Administration]] (FDA) refers to these agents as '''insulin receptor ligands''' (because, like insulin itself, they are [[ligand (biochemistry)|ligands]] of the [[insulin receptor]]), although they are usually just referred to as insulin analogs or even (loosely but commonly) just insulin (without further specification).
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 A [[meta-analysis]] completed in 2007 and updated in 2020 of numerous [[randomized controlled trials]] by the international [[Cochrane Collaboration]] found that the effects on blood glucose and glycated haemoglobin A1c [[Glycated hemoglobin|(HbA1c)]] were comparable, treatment with [[Insulin glargine|glargine]] and [[Insulin detemir|detemir]] resulted in fewer cases of [[hypoglycemia]] when compared to [[NPH insulin]].  Treatment with detrimir also reduced the frequency of serious hypoglycemia.  This review did note limitations, such as low glucose and HbA1c targets, that could limit the applicability of these findings to daily clinical practice.
-In 2007, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) [https://web.archive.org/web/20080208123345/http://www.iqwig.de/index.658.en.html report], concluded that there is currently "no evidence" available of the superiority of rapid-acting insulin analogs over synthetic human insulins in the treatment of adult patients with type 1 diabetes.  Many of the studies reviewed by IQWiG were either too small to be considered statistically reliable and, perhaps most significantly, none of the studies included in their widespread review were blinded, the gold-standard methodology for conducting clinical research.  However, IQWiG's terms of reference explicitly disregard any issues which cannot be tested in double-blind studies, for example a comparison of radically different treatment regimes.  IQWiG is regarded with skepticism by some doctors in Germany, being seen merely as a mechanism to reduce costs.  But the lack of study blinding does increase the risk of bias in these studies. The reason this is important is because patients, if they know they are using a different type of insulin, might behave differently (such as testing blood glucose levels more frequently, for example), which leads to bias in the study results, rendering the results inapplicable to the diabetes population at large.  Numerous studies have concluded that any increase in testing of blood glucose levels is likely to yield improvements in glycemic control, which raises questions as to whether any improvements observed in the clinical trials for insulin analogues were the result of more frequent testing or due to the drug undergoing trials.{{citation needed|date=May 2022}}
+In 2007, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) [https://web.archive.org/web/20080208123345/http://www.iqwig.de/index.658.en.html report], concluded that there is currently "no evidence" available of the superiority of rapid-acting insulin analogs over synthetic human insulins in the treatment of adult patients with type 1 diabetes.  Many of the studies reviewed by IQWiG were either too small to be considered statistically reliable and, perhaps most significantly, none of the studies included in their widespread review were blinded, the gold-standard methodology for conducting clinical research.  However, IQWiG's terms of reference explicitly disregard any issues which cannot be tested in double-blind studies, for example a comparison of radically different treatment regimes.  IQWiG is regarded with skepticism by some doctors in Germany, being seen merely as a mechanism to reduce costs.  But the lack of study blinding does increase the risk of bias in these studies. The reason this is important is because patients, if they know they are using a different type of insulin, might behave differently (such as testing blood glucose levels more frequently, for example), which leads to bias in the study results, rendering the results inapplicable to the diabetes population at large.  Numerous studies have concluded that any increase in testing of blood glucose levels is likely to yield improvements in glycemic control, which raises questions as to whether any improvements observed in the clinical trials for insulin analogues were the result of more frequent testing or due to the drug undergoing trials.
 In 2008, the [[Canadian Agency for Drugs and Technologies in Health]] (CADTH) found, in its comparison of the effects of insulin analogues and biosynthetic human insulin, that insulin analogues failed to show any clinically relevant differences, both in terms of glycemic control and adverse reaction profile.
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 [[Category:Peptide hormones]]
 [[Category:Peptide therapeutics]]
+</translate>