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Oral insulins still under development

Dr.
Posted by Dr. Lars Bochmann on Feb 23, 2017 5:00:00 PM

With oral insulin type 1 diabetes treatment may see higher compliance

Even today, after decades of intense work on developing new insulins and novel methods of delivery, subcutaneous injection remains to be the only method available for most patients with diabetes. Such injections can be unpleasant, but for many patients even more troublesome is the discomfort of injecting themselves in public spaces potentially leading to skipped doses. This may be the case even more for young patients, mostly suffering from type 1 diabetes, who suffer higher social pressures. Lastly, undesirable aesthetic side effects such as lipohypertrophy further drive the patients' desire for alternative ways to administer the much needed insulin. If oral insulin pills were available, increased patient compliance may be observed and better metabolic control could be achieved in more patients. 

Oral insulin pills

Oral insulin pills are under development but not ready for market yet

Despite extensive research into oral insulin medications over the past 90 years,  no company has managed to successfully market insulin in the form of a pill or a tablet. In a recent review, published by Profil scientists, we had identified thirteen companies working on the development of oral insulin delivery. However, the rate at which clinical data had been published by these companies is less than reason for enthusiasm. Only six of those thirteen companies have published any clinical data in the 5 years that were analysed (2009-2014). Interestingly, these make up only 4% of all publications on oral insulins in this time-period. This indicates that many developments were still at the pre-clinical stage. It would certainly be a great advancement in patient care to finally have viable options available that do not require injection of insulin.

The review mentioned above is a good starting point for further research into the topic. Also if you are currently working on projects in this direction, the review will be of help to your understanding of the state of academic research and commercial developments until 2014.

Clinical trial design for oral insulins

Profil has conducted clinical pharmacology investigations with a number of oral insulin formulations. We know that an oral insulin tablet gets absorbed through the intestinal walls and can act to lower blood glucose. The trials we have conducted have shown that it is necessary to administer high insulin doses to overcome challenges of low bioavailability and biopotency. Furthermore, the absorption rates and effects are highly variable and food intake can severely hamper the efficacy of oral insulin medications. These challenges need to be addressed during drug development and to date have been the main hurdle for the development of a successful oral insulin pill.
Developing companies need to address this by working on improved insulin structures as well as tablet formulations. This approach may lead to an accelerated insulin absorption, allowing the medicine to be taken shortly before a meal, and to produce a consistent glucose-lowering effect. These are the obstacles standing in the way of the commercialization of the long-sought oral insulin.

Profil online seminar on alternative routes of insulin administration

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Due to the industry's interest to develop oral insulin pills, Profil has come up with optimized trial designs to study oral insulin medications in the clinical trial setting. A lot of the expertise needed to design an ideal trial to understand the efficacy and bioavailability of such oral insulin, we presented in a online seminar on the development of oral insulins. We reviewed past developments in this area as well as the current stage of research. If you are interested in oral insulins or other alternative routes of administration, then this online seminar should definitely be of interest to you. 

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Topics: Clinical Trials in Diabetes