Informal, Open Label Clinical Trial Results
- Duration of Hyperglycemia Reduced by Factor of 3
- Informal Clinical Study: Six Type 1 diabetes patients, two of whom were Tommy and Gary are company founders
- Open-Label Study: Patients during hyperglycemic periods took insulin and chose themselves whether or not to also add a prototype formulation comprising Auxulin's active ingredient.
- Limited A1C Data: A1C data was only evaluated for the two founders. The other subjects did not administer Auxulin often enough to expect a meaningful A1C impact, and their A1C percentages were not evaluated.
- We conducted an informal, open-label, proof-of-concept human clinical study among Type 1 diabetics in the “friends and family” category. A crossover design was used.
- When the subjects were significantly hyperglycemic, they self-medicated by following either the active control procedure or the experimental procedure as described herein. Sometimes a subject followed the active control procedure, and other times the subject followed the experimental treatment procedure.
- For the active control, the significantly hyperglycemic Type 1 subject consumed eight ounces of water, took insulin as appropriate in accordance with their habits and insulin pump recommendation, and waited until their blood glucose levels were no longer hyperglycemic. This is the current standard practice treatment among Type 1 diabetics. Blood glucose levels were recorded (via glucose meter with finger prick test strips) at the outset and every 15 minutes after the intervention was commenced until blood glucose levels dropped to less than 180 mg/dL.
- For the experimental treatment tests, the significantly hyperglycemic subject consumed at least 8 ounces of water along with a therapeutic dosage of a prototype formulation comprising Auxulin's active ingredient, took insulin as appropriate in accordance with their habits and pump recommendation, and waited until their blood glucose levels were no longer hyperglycemic. Typically, the dosage was administered within five minutes of the insulin administration. Blood glucose levels were recorded at the outset and every 15 minutes after the intervention was commenced until blood glucose levels dropped to less than 180 mg/dL. The average starting blood glucose levels were approximately 320 mg/dL for the two groups.
- Clearly, when treated with the experimental procedure, subjects experienced reduced duration and magnitude of hyperglycemic events. On average, hyperglycemic blood glucose levels were dropped below hyperglycemic levels in less than one hour when the Type 1 diabetics were subjected to the experimental treatment procedure. In contrast, when subjected to the active control procedure, it took an average of roughly 2.5 hours to return to sub-hyperglycemic blood glucose levels of less than 180 mg/dL. Accordingly, when subjected to the active control treatment, which is the long-time standard of care for diabetic individuals, the hyperglycemic period was about three times longer than when individuals self-administered the experimental treatment procedure. This is an enormous difference, particularly given (i) the physical discomfort associated with hyperglycemia, (ii) the risk of ketoacidosis when high levels of hyperglycemia persist for long periods, and (iii) that the duration and magnitude of hyperglycemic events is believed to correlate closely with A1C levels, which correlate with long-term complications of diabetes.
While we have only done limited testing for Type 2 diabetics, we believe Auxulin should reduce the magnitude and duration of Type 2 hyperglycemic events, especially for those Type 2 diabetics who use insulin injections.
- Experimental evidence suggests that more sodium salts are not necessarily bad for diabetics. For example, a recent paper describing a prospective cohort study looking at the correlation between sodium and outcomes in Type 2 diabetic patients concluded that: “lower 24-h urinary sodium excretion was paradoxically associated with increased all-cause and cardiovascular mortality.” (1)
- Therefore, too little sodium can increase the risk of long term complications like cardiovascular disease.
- In a nationwide multicenter study (the FinnDiane Study) between 1998 and 2002, 2,807 enrolled adults with type 1 diabetes were prospectively followed to look at the correlation between sodium excretion and health outcomes, yielding the following results. The study concluded that, “Urinary sodium excretion was nonlinearly associated with all-cause mortality, such that individuals with the highest day sodium excretion was inversely associated with the cumulative incidence of ESRD, such that individuals with the lowest sodium excretion had the highest cumulative incidence of ESRD.” ily urinary sodium excretion, as well as the lowest excretion, had reduced survival. This association was independent age, sex, duration of diabetes, the presence and severity of chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] and log albumin excretion rate), the presence of established cardiovascular disease, and systolic blood pressure. During follow-up, 126 patients developed ESRD (4.5%).”
- (2)Therefore, the high amount of elemental sodium contained in Auxulin’s formulation has a small risk, which we believe is a justifiable risk to reduce the more immediate risk of ketoacidosis for a hyperglycemic person. Moreover, we believe that the long term risks associated with higher A1C levels (for individuals not taking Auxulin) are likely to be much greater than any long-term increase in risk of heart disease that a diabetic might encounter as a result of a lifetime of using Auxulin. In other words, we believe Auxulin will reduce both short term and long-term health risks. Any concerns about an individual’s health should be brought up to their health care provider(s).
- For more information please see:
- (1) (http://care.diabetesjournals.org/content/34/3/703.short)
- (2) http://care.diabetesjournals.org/content/34/3/703.short)
No, Auxulin is meant to reduce your insulin resistance, caused by dehydration and hyponatremia, and augment the speed with which your insulin works. You still need to take your insulin and other treatments for high blood sugar alongside Auxulin.
Auxulin’s initial conception was an attempt to develop a convenient and affordable product that would be taken to prevent the onset of diabetic ketoacidosis (DKA). Auxulin’s formulation contains many of the same ingredients provided in intravenous fluids given to diabetic patients when they are hospitalized with DKA. However, any patient who enters a state of DKA should consult with their primary care physician immediately to seek treatment.
Auxulin is not regulated as a drug and thus is not approved by the FDA. The active ingredients in Auxulin are classified as ‘generally regarded as safe” by the FDA. We plan to run a more robust clinical study in the future, with which to petition the FDA for approval
Auxulin should be used as a rescue medication for extremely high blood sugar levels, and at most no more than four doses of up to three tablets, based on body weight, should be taken per week.
Ask your doctor or primary care provider.
The maximum we’d recommend is 6 tablets per day.
We believe the risk when using Auxulin is significantly reduced relative to the conventional course of treatment (i.e., insulin/water/wait). Often, when blood sugar levels do not drop quickly enough, Type 1 diabetics will self-administer additional insulin, which can eventually lead to blood sugar levels dropping significantly below the desired level. We have not seen that at all with Auxulin. With Auxulin, less insulin is used since blood sugar levels drop rapidly, and Auxulin’s formulation will not independently reduce blood sugar levels.
This is because Auxlin’s patented formulation is classified as GRAS (Generally regarded as safe) by the FDA. We chose to bring Auxulin to market as a supplement instead of a drug for 3 main reasons:
- Decreased cost to patient
- Decreased time to market
- Decreased complexity in purchasing (no need to call your insurance provider to see if its on formulary)
Auxulin works by addressing the underlying causes of insulin resistance.. By addressing these causes, Auxulin can be used to supplement traditional approaches for blood glucose management when blood sugar levels are high and should be used as a rescue medication. It should be taken whenever a diabetic reaches a high enough blood sugar level, with a high level being unique to each diabetic. Take 1 tablet of Auxulin and 8 ounces of water per 70 pounds of body weight, in addition to your current blood glucose management. If there’s been no significant change to BG within 40 minutes, take some additional Auxulin.