Insuline Reports Significant Initial Results in a Clinical Feasibility Study Which Tested the Impact of Local Treatments on Basal Insulin (Long Acting Insulin)

PETACH-TIKVA, Israel, November 3, 2016 /PRNewswire/ --

Insuline Medical (TASE: INSL.TA), A medical device research, development and marketing company of injection site treatment and stabilization technologies (ISTS) in order to improve the effectiveness of subcutaneously delivered drugs, announced a significant initial results in a clinical feasibility study with regard to the procedures completed so far. The aim of the study was to test the impact of local treatments at the injection site of long acting insulin (insulin glargine) on insulin levels in the blood and, consequently, the non-invasive influence on blood glucose levels.  

Basal insulin is typically injected once a day and, unlike mealtime insulin that is injected around meals, basal insulin is intended to keep blood glucose levels stable throughout the day. Treatment with basal insulin is typically the first line of treatment after treatment with oral drugs.  

Insulin glargine, which is a commonly-used basal insulin drug, resides after injection in a subcutaneous depot from which it is slowly released into the circulation to keep blood glucose levels stable throughout the day.

In the above-mentioned study, the effects of local treatments applied to the skin at the basal insulin injection site on glucose and insulin levels in the blood were tested. The treatments applied included cooling, heating, massage, vibration and electrical stimulation. The treatments were tested in relation to their impact on increasing and decreasing the release rates of basal insulin from its subcutaneous drug depot into the circulation, as well as the effects of those rate changes on blood glucose levels.

The company has now finalized testing of the local heating and cooling effects on blood glucose levels in 14 type I diabetic subjects that completed three days of testing, including control, "cool" and "heat" tests.

During the study subjects injected their daily basal insulin dose in the morning. The experiment started two hours post injection and local interventions were applied to the skin at the injection site for 4 hours, depending on the type of testing conducted that day.

The obtained results showed that the subjects' blood glucose levels increased, on average, by 41, 55, and 54 mg/dl after cooling the injection site-skin for 2, 3 and 4 hours respectively. Subjects' blood glucose levels were reduced by 16, 25 and 44 mg/dl following heat application to the skin for 2, 3, and 4 hours respectively.  The above reported changes in blood glucose levels are with respect to the blood glucose levels measured on the control-testing day.

Prof. Itamar Raz, Clinical Consultant to the Company: "The observed results are clinically significant as an increase of 40-50 mg/dl following a cooling, for example, can mean the difference between a hypoglycemic state, or blood glucose level within the normal range.  I believe the Company should continue to examine this technology on a larger number of subjects in conditions mimicking real-life settings to test the impact of this technology on hypoglycemia rates in order to bring new technologies to diabetic patients treated with insulin injections" .

Based on the results obtained so far, the Company is of the opinion that the option to develop a device based on this technology should be examined. Such a device would enable better control of blood glucose levels for diabetics on glargine basal insulin therapy. Currently, achieving good glycemic control is still a challenge: for example, when sleeping, patients are exposed to hypoglycemia and hyperglycemia events. The Company believes that a device which will enable better control of patients' blood glucose levels non-invasively could help reduce the amount of hypoglycemia and hyperglycemia events during sleep for patients treated with insulin glargine as basal insulin therapy.

Gabby Bitton, VP R&D Insuline: "The recently received FDA approval for Minimed's 670G  closed loop hybrid system - which is based on controlled changes in basal insulin infusion rates - and the effort invested by companies developing technological solutions aimed at better and more convenient control of diabetics' blood glucose levels, indicate the existing need for such solutions. Combining Insuline's ISTS technology with a continuous glucose sensor can facilitate future development of such a solution for patients on glargine basal insulin therapy. Based on the sensor readings, and in case of increased risk for a hypoglycemic event, cooling can be initiated which would reduce the release rate of insulin from the basal insulin drug depot and would allow - as was seen in the experiment - an increase in patients' blood glucose levels by  40-50 mg/dl. Such an increase is equivalent, for example, to the difference in blood glucose levels between normal and low blood glucose levels" .

Based on these results the Company estimates that there may be a potential for this technology for companies involved in the field of glargine basal insulin, as well as for companies involved in the field of continuous glucose sensors.

Eyal Lewin, CEO Insuline:  "Following the study results, the company intends to approach companies active in the areas of long acting insulin, continuous glucose sensors and diabetes management to seek for potential collaborations which would allow commercialization of Insuline's technology with insulin glargine".

Clarification:

For clarification, and as was described above, the study was conducted with 14 patients only. It is further clarified that the Company's assumptions with regard to device development and the potential collaborations with other companies include forward‐looking information, as defined in the Israeli Securities Law, 5728‐1968. Such information is uncertain, may not be accurately assessed in advance, and its realization or non‐realization is affected, inter alia, by the testing of the technology in large numbers of patients in real-life settings, and with the cooperation of the other companies. Also, there is no certainty that the Company would complete the development of a product based on the Company's technology or that the developed product (if developed) would become commercial.

About Insuline Medical  

Insuline Medical (http://www.insuline-medical.com/) , a publicly-listed Israeli medical device company,, is developing the injection site treatment and stabilization technology (ISTS), first implemented in mealtime insulin, using the InsuPad device, which has the CE, Canadian CE, Australian TGA and Israeli AMAR certificates. The Company is seeking collaborations with drug companies and companies developing drug delivery devices, to implement the ISTS technology with other drugs, including long acting insulin.  

For further information:
Amalia Herszkowicz
V.P. Business Development & Global Marketing 
+972-3-9301094
[email protected]

SOURCE Insuline Medical