 "Diabetes cure: An insight into research post exit of glitazones")
Where there is sugar, there are ants and ants are considered to be the most diligent living forms. But when it comes to the sugar disease, ie, diabetes, it is highly challenging to achieve the desired results in clinical trials but also the right investigators and funding for those trials too.
Needless to say, the pharmaceutical industry is always in the pursuit of new drugs for diabetes and big players are continuously in the spree to achieve the required milestones in their field. Diabetes falls under the category of endocrinology when it comes to a pharmacological classification. Out of the 10 new drug applications for endocrinology disorders approved by the FDA in 2014, the number of drugs approved for type 2 diabetes was 5, according to data published by leading clinical trial tracking firm, Center Watch. All of these have been launched by big pharmaceutical companies in the time frame of January-October 2014 (refer Figure 1).
This is higher than the number of diabetes drugs approved in 2013 when there were only 2 approvals, one for Invokana (canagliflozin) by Janssen Pharmaceuticals in April 2013 and another for Nesina (alogliptin) by Takeda in January 2013. Needless to say, trends are working in favour of clinical trials for the sugar pill. However for the diabetes disease in 2015, the FDA has been highly active in approving Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus in September 2015.
At least 100 new medicines are in the phase of research and development for type 2 diabetes and nearly 50 percent of them were in phase 1 clinical trials in the year 2014.
Since 2001, the number of registered clinical trials in diabetes in phase 1 has been in the range of 10-12 percent of the total registered diabetes trials by start date. Till 2015, the average component of phase 1 clinical trials in diabetes has been 10.13 percent. For the phase 2 clinical trials by start date from 2001, the percentage component has been affected by crests and troughs with highest percentage being nearly 15 percent of the total number in 2007 to as low as 8-9 percent in the years 2013-2015.
Needless to say, there have been failures in diabetes clinical trial results or the clinical trials may have been called off due to lack of funding or non-availability of investigators. The fall in the numbers can also be attributed to the external environment affecting the pharmaceutical industry where companies have been under pressure from generic drugs makers and regulators combined.
However, hope is still not lost because the phase 3 and phase 4 share of diabetes clinical trials by start date presents a promising picture. The registration of phase 3 and phase 4 has been on the rise since 2003 and reached a peak component percentage of nearly 50 percent in the years 2004-2005 indicating the rise of clinical research in diabetes. Phase 3 and phase 4 clinical trials component together maintains a healthy average of nearly 39 percent in terms of the total new clinical trials registered for diabetes by start date.
Another healthy sign for the diabetes clinical trials is that majority (nearly 50 percent) of these clinical trials is industry funded and most of the funding is available on an optimum coverage for all phases of clinical trials by start date in diabetes. Since phase 3 occupies large percentage in the global pharma companies in diabetes clinical trials (804 trials; 33%) of the total trials, maximum funding is required in this phase.
From the above inferences, it is evident that times are not far when diabetes will be easily curable with the availability of a larger number of medicine options to the patients.
____________________________________________________________________________________________________
Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
Needless to say, the pharmaceutical industry is always in the pursuit of new drugs for diabetes and big players are continuously in the spree to achieve the required milestones in their field. Diabetes falls under the category of endocrinology when it comes to a pharmacological classification. Out of the 10 new drug applications for endocrinology disorders approved by the FDA in 2014, the number of drugs approved for type 2 diabetes was 5, according to data published by leading clinical trial tracking firm, Center Watch. All of these have been launched by big pharmaceutical companies in the time frame of January-October 2014 (refer Figure 1).
This is higher than the number of diabetes drugs approved in 2013 when there were only 2 approvals, one for Invokana (canagliflozin) by Janssen Pharmaceuticals in April 2013 and another for Nesina (alogliptin) by Takeda in January 2013. Needless to say, trends are working in favour of clinical trials for the sugar pill. However for the diabetes disease in 2015, the FDA has been highly active in approving Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus in September 2015.
At least 100 new medicines are in the phase of research and development for type 2 diabetes and nearly 50 percent of them were in phase 1 clinical trials in the year 2014.
Figure 1: Diabetes drugs launched by pharma companies during Jan-Oct 2014
There has been an increase in diabetes clinical trials since 2001 when the number of registered clinical trials by start date increased by nearly 3 fold from 2001 to 2004. The increase in the registered trials for diabetes reached its peak in 2009 to around 500 trials. Post 2009, the number of registered diabetes clinical trials remained stable in the 400 plus range but the year on year growth of registered diabetes trials was on the decline.Since 2001, the number of registered clinical trials in diabetes in phase 1 has been in the range of 10-12 percent of the total registered diabetes trials by start date. Till 2015, the average component of phase 1 clinical trials in diabetes has been 10.13 percent. For the phase 2 clinical trials by start date from 2001, the percentage component has been affected by crests and troughs with highest percentage being nearly 15 percent of the total number in 2007 to as low as 8-9 percent in the years 2013-2015.
Needless to say, there have been failures in diabetes clinical trial results or the clinical trials may have been called off due to lack of funding or non-availability of investigators. The fall in the numbers can also be attributed to the external environment affecting the pharmaceutical industry where companies have been under pressure from generic drugs makers and regulators combined.
However, hope is still not lost because the phase 3 and phase 4 share of diabetes clinical trials by start date presents a promising picture. The registration of phase 3 and phase 4 has been on the rise since 2003 and reached a peak component percentage of nearly 50 percent in the years 2004-2005 indicating the rise of clinical research in diabetes. Phase 3 and phase 4 clinical trials component together maintains a healthy average of nearly 39 percent in terms of the total new clinical trials registered for diabetes by start date.
Another healthy sign for the diabetes clinical trials is that majority (nearly 50 percent) of these clinical trials is industry funded and most of the funding is available on an optimum coverage for all phases of clinical trials by start date in diabetes. Since phase 3 occupies large percentage in the global pharma companies in diabetes clinical trials (804 trials; 33%) of the total trials, maximum funding is required in this phase.
From the above inferences, it is evident that times are not far when diabetes will be easily curable with the availability of a larger number of medicine options to the patients.
____________________________________________________________________________________________________
Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
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