New drug trial in Manchester could help relieve the pain of diabetes
clinical trial involving patients from Manchester hopes to find an
effective and non-addictive drug to relieve diabetic neuropathy, a
painful complication of the condition.
A trial taking place at the Trafford General Hospital will be
the first in the world to investigate the potential of an
innovative drug for chronic pain conditions, such as diabetic
neuropathy. For many patients this condition is unsatisfactorily
managed by current drugs.
"Patients with diabetic neuropathy experience a painful tingling
in their nerves, hands and feet, even with well-managed diabetes.
For many, current treatments are not effective in managing pain and
new alternatives will be welcomed by patients," comments Dr Ajith
George, Consultant in diabetes and endocrinology, who is delivering
the trial at Trafford General Hospital.
Pharmaleads, the company leading the clinical trial, is looking
to recruit patients with diabetes from Manchester to take part in
the four week study which could help change the impact of the
disease for future generations.
"With the help of volunteers we may uncover a more effective
treatment to manage the pain that some people with diabetes face,"
adds Dr George. "Trafford General Hospital was chosen as it
has a comprehensive diabetes service, which includes a foot
service. In our clinics, we see a considerable amount of
neuropathy and are often frustrated by the inability to achieve
effective pain relief."
Trafford General Hospital is still looking for more local people
to take part in the trial, which is supported by the NIHR.
The trial will investigate a new drug called PL37. This is a
Dual Enkephalinase Inhibitor or "DENKI" - a novel and exciting
class of analgesic which can prolong the body's own natural
Earlier studies with patients have shown that DENKI PL37
effectively targets the actual site of pain and enhances the
benefit of other pain medications - and, unlike opiates such as
morphine, is non-addictive. It was very well tolerated even at high
oral doses, although some subjects reported mild side-effects such
as loose stools and headaches.
However it is DENKIs' mechanism in the body that is attracting
excitement within the science community. The body's natural
painkillers degrade quickly, but DENKIs are able to prolong the
life of these peptides; in essence, assisting the body's own
natural pain relieving processes.
The study is open to patients with diagnosed diabetic neuropathy
(type 1 or type 2 diabetes) who are currently prescribed a pain
medication which is not effective enough. The trial will explore if
DENKI PL37 is effective in reducing pain intensity. The Trafford
General Hospital is one of 11 hospitals in the UK taking part in
If you are a person with diabetes and feel your current pain
treatment is unsatisfactory, and would like to find out more
information on the 'DENKI PL37 for diabetic neuropathy' trial, you
can ask your physician if you can be referred to the investigative
site at the Trafford General Hospital.
Alternatively, for more information contact Pharmaleads on 0800
Notes to editors
About the clinical trial
A 4 week phase 2a, multicentre, randomised, double-blind,
placebo-controlled add-on study into safety, tolerability and
efficacy of 200 mg t.i.d. of PL37 in patients with peripheral
neuropathic pain of diabetic origin treated with pregabalin or
Participants will receive PL37 or placebo, in addition to their
existing treatment of either pregablin or gabapentin. PL37 or
placebo will be taken as a capsule three times a day before each
Diabetes Day - 14th November
Each year, World Diabetes Day, which is co-ordinated by
the International Diabetes Federation (IDF), carries a particular
theme and between 2014 to 2016 the theme is healthy living and
diabetes. For further information see: http://www.idf.org/wdd-index/.
Central Manchester University Hospitals NHS Foundation
Trust is a leading provider of specialist healthcare
services in Manchester, treating more than a million patients every
year. Its eight specialist hospitals (Manchester Royal Infirmary,
Saint Mary's Hospital, Royal Manchester Children's Hospital [RMCH],
Manchester Royal Eye Hospital, University Dental Hospital of
Manchester and Trafford Hospitals) are home to hundreds of world
class clinicians and academic staff committed to finding patients
the best care and treatments. (www.cmft.nhs.uk)
Founded in 2000 and based in Paris, France, Pharmaleads has
developed a coherent set of first-in-class molecules, thanks to its
world-class medicinal chemistry expertise, providing solutions in
pain treatment. Pharmaleads designs and manages the early-stage
development of small protease-inhibiting compounds for diagnostic
and therapeutic use.
The National Institute for Health Research
(NIHR) is funded by the Department of Health to improve
the health and wealth of the nation through research. Since its
establishment in April 2006, the NIHR has transformed research in
the NHS. It has increased the volume of applied health research for
the benefit of patients and the public, driven faster translation
of basic science discoveries into tangible benefits for patients
and the economy, and developed and supported the people who conduct
and contribute to applied health research. The NIHR plays a key
role in the Government's strategy for economic growth, attracting
investment by the life-sciences industries through its world-class
infrastructure for health research. Together, the NIHR people,
programmes, centres of excellence and systems represent the most
integrated health research system in the world. For further
information, visit the NIHR website (www.nihr.ac.uk