A new drug, Trajenta, has been proven to work for type 2 cultural diabetes treatment programs after a lengthy but successful clinical trial process.
An extended clinical trial of the drug linagliptin (Trajenta), conducted for a group of over 2,000 patients from 32 countries with type 2 diabetes, confirmed the drug as safe and effective for lowering and maintaining blood sugar levels for up to 102 weeks.
Fundamentally, all forms of diabetes are a condition where a person has high blood sugar, which means there’s too much sugar (glucose) in the blood for the body to process normally. The effects of this condition begin with the three classic symptoms of hyperglycemia, frequent urination, increased thirst, and increased hunger.
If untreated, diabetes can produce many serious long-term complications including cardiovascular disease (heart disease), kidney disease (renal failure), damage to the eyes (retinopathy), damage to the nerves (neuropathy) and in severe incidents, diabetic coma.
With modern type 2 diabetes treatment, diabetes is rarely fatal in its own right, but it is a major contributor to many other illnesses, many of which are fatal.
The key component in diabetes is insulin. Insulin is a hormone produced by the pancreas and its job is to regulate the blood sugar level of the body. In a way it acts like a stimulant to the liver, muscle and fat tissue to take glucose (blood sugar) from the blood and either metabolize (use) it or store it as fat. Lack or failure of insulin to do this job is the cause of diabetes.
Of the three major types of diabetes, type 2 is by far the most common – and becoming more common in the every part of the world where poor diet and health habits are the norm. Unlike type 1 diabetes, where there is little or no production of insulin, doctors characterize type 2 diabetes by sometimes-low insulin production and almost always a reduced sensitivity to insulin.
That is, various organs, notably the liver and muscles, no longer respond to insulin normally. They fail to either metabolize or store the glucose, which results in an increased glucose level in the blood.
Research for Type 2 Diabetes Treatment
Research for type 2 diabetes treatment medication has generally targeted two approaches: one is to reduce the production of glucose by the liver, the other by improving insulin sensitivity. Linagliptin is a drug of the second approach. It belongs to a family of drugs, gliptins, which are DPP-4 inhibitors (dipeptidyl peptidase 4).
That is, they block the action of DPP-4, one of the key enzymes for the process of metabolizing glucose. Too much DPP-4 in the blood can break down one of the trigger mechanisms, known as incretins, which signal the pancreas to produce insulin.
This is a type pathway (or chain) of chemical processes – incretins such as GLP-1 fail to signal the production of more insulin because excess DPP-4 breaks them down. Linagliptin works because it blocks the effect of DPP-4.
Linagliptin is one of seven principal gliptins drugs (for example, sitagliptin, dutogliptin and vildagliptin), and you might wonder ‘Why so many similar drugs?’
The answer is found in the reason for the extensive clinical trials of linagliptin. In one way or another, all of the gliptins drugs work – they block DPP-4; but they don’t all work equally well. Some of the drugs have stronger side effects, others have a limited period of effectiveness, some are expensive or difficult to administer.
These problems show up in the clinical trials, or sometimes after they are commercially released, according to aged care melbourne. Researchers continue to look for variations that do well in all areas. Linagliptin is a result of that search and the latest to achieve U.S. Food and Drug Administration approval (2011).
The new study, published in the August issue of the International Journal of Clinical Practice, is the result of a massive 32-country Phase III clinical trial. It followed 2,121 individuals who had previously taken part in a 24 week randomized, double-blind, placebo controlled clinical trial – and followed them for another 78 weeks (a total of both trials, 102 weeks or almost two years).
With this many patients and over a relatively lengthy period, the trial tested the drug not only for effectiveness but also for the other factors such as durability, side effects (especially weight gain) and without risk of developing a low blood sugar condition (hypoglycemia).
The linagliptin was administered orally once a day and sometimes in combination with other treatment drugs. The study group had an average age of 57.5 years, roughly half male, half female, and half diagnosed with Type 2 diabetes more than five years ago.
The results of the trial were highly positive. Severe adverse side effects were low at 3.8% of the group, which accounted for a dropout rate of 3.4%. The general side effects were classified as mild or moderate. Episodes of low blood sugar were common, about 14%, but most of these were among the people taking other drugs with the linagliptin.
As the co-author of the study, David R. Owens of Cardiff University (Wales, UK) said of the results, “They also provide evidence that supports the efficacy and tolerability profile seen in the previously reported 24 week studies. Therefore, this extension study shows that linagliptin is an effective and well tolerated therapy for the long-term management of Type 2 diabetes.”
In the broad scheme of drug development, a successful Phase III trial like this one is not rare, but it is appreciated.