News of the advancements in Diabetes research, which include bringing us steps closer to possible cures and improvements in technology, are heartening to all whose lives have been impacted by the disease.
One segment of this research has been dedicated to slowing the natural progression of Type 1 Diabetes (or Diabetes Mellitus) by looking to extend the honeymoon phase. A Swedish company, Diamyd Medical, has been at the forefront of this research and now is conducting human clinical trials. The objective of these trials is exploring the possibility of the body to preserve its beta cells, thereby of extending the production of insulin.
Type 1 Diabetes, as an autoimmune disease, means that the body fights itself and destroys its own insulin-producing function. Beta cells, which reside in the pancreas, produce our body’s insulin, and, with the onset of diabetes, thus are destroyed by the immune system.
The destruction of beta cells usually occurs over a long period of time. When too many beta cells are destroyed or damaged, your body loses the ability to produce enough insulin on your own to control your blood glucose levels, which then leads to the diagnosis of being an insulin-dependent diabetic. By the time someone is diagnosed with Type 1, he usually has lost up to 80% of beta cell function.
During the first few months after diagnosis, the body continues to produce some insulin on its own that is not destroyed by the body’s immune system. During this time, one’s insulin needs are not as high as they will be later on. This is called the honeymoon phase, and can last a few weeks or even a few years.
Preserving insulin production results in better BG control over time and can reduce long-term complications of Type 1, including retinopathy and neuropathy.
The Importance of GAD
A protein called glutamic acid decarboxylase (GAD) has been identified as helping people to keep making their own insulin by preserving beta cells. It resides in human islet cells as well as in the brain and other neurological tissue. GAD and its role in Type 1 diabetes was identified in the 1970s by Diamyd researchers. In the 1980s, research conducted determined that GAD was a good immunological predictor of someone developing Type 1 in the future.
History Of The Trials
The first trials of GAD took place in 1996 at UCLA, and were conducted by Diamyd. During these trials, it was demonstrated that the use of GAD protein can prevent Type 1 in mice.
Diamyd next started human trials in 2004. At this point in time, they worked with 70 recently diagnosed Type 1 children, aged 10 to 18. During these trials, the children were divided into two groups: one group receiving injections of a placebo and a second group receiving injections of a Diamyd vaccine containing GAD. After 15 months, those that had been treated with the Diamyd experienced half of the reduction in their own insulin production as compared to the participants given the placebos. Similar results held true at the 21-month follow up.
Today, the company is running Phase III of its trials. During these trials, two out of three participants will receive the active drug, and one out of three will receive the placebo. For this specific phase, Diamyd is looking for children between the ages of ten and twenty years of age who have been diagnosed with Type 1 within the last three months. The trial will last two and a half months, during which time participants will need to visit a clinic eight times. As with prior trials, the Diamyd drug is received via injections. Currently, the company is looking for additional participants for its clinical studies. Over thirty sites are located in the U.S.
As mentioned above, if you are interested in the Diamyd study, you can find out more at DiaPrevent. There trials are open to recently diagnosed Type 1s between the ages of 10 and 20 years of age. In addition, as I discussed in my last post, TrialNet, which is an international network of researchers conducting research on Type 1, is conducting clinical trials using Diamyd’s GAD protein to extend the honeymoon period (or preservation of beta cell production) in newly diagnosed Type 1s who are between the ages of three and 45 years of age.
I will conclude by saying that these are clinical trials, and all information about these trials should be evaluated and considered - both the possible positive effects as well as any potential adverse affects - before embarking. Do the research, talk to your endocrinologist or CDE, and whenever possible, include the input of your child.
No matter what, each advancement in research brings more hope of better management, few complications and even a cure to the diabetes community.