Informal, Open Label Clinical Trial Results
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, using a crossover design. When the subjects were significantly hyperglycemic, they self-medicated by following either the active control or experimental procedure as described here.
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. Blood glucose levels were recorded 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. Blood glucose levels were recorded 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 both groups.
The experimental procedure resulted in reduced duration and magnitude of hyperglycemic events. On average, hyperglycemic blood glucose levels dropped below hyperglycemic levels in less than one hour when 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.
This is an enormous difference, particularly given the physical discomfort associated with hyperglycemia, the risk of ketoacidosis when high levels of hyperglycemia persist for long periods, and that the duration and magnitude of hyperglycemic events are 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 diabetics should not necessarily avoid sodium. For instance, a recent paper based on a prospective cohort study, which looked 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, insufficient sodium intake can increase the risk of long-term complications such as cardiovascular disease.
In the FinnDiane Study, a nationwide multicenter study between 1998 and 2002, 2,807 adults with type 1 diabetes were followed prospectively to assess the correlation between sodium excretion and health outcomes. 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." (2) This means that both the highest and lowest levels of daily urinary sodium excretion were associated with reduced survival. The study also found that this association was independent of 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 (4.5%) developed ESRD.
Therefore, the 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 the 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. However, any concerns about an individual's health should be discussed with their healthcare provider.
For more information, please visit: (1) http://care.diabetesjournals.org/content/34/3/703.short (2) http://care.diabetesjournals.org/content/34/3/703.short
Auxulin is designed to help reduce insulin resistance caused by dehydration and hyponatremia, and improve the effectiveness of insulin. However, it is important to note that Auxulin is not a replacement for insulin or other treatments for high blood sugar. Instead, it should be used in conjunction with these treatments as prescribed by your healthcare provider.
Auxulin was originally designed as an affordable and convenient product to prevent diabetic ketoacidosis (DKA) by reducing insulin resistance caused by dehydration and hyponatremia, and enhancing the speed of insulin action. However, if a patient experiences DKA, they should immediately consult with their primary care physician for appropriate treatment. It is important to note that while taking Auxulin, you still need to continue with your insulin and other treatments for high blood sugar.
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 that the risk of rebound hyperglycemia is significantly reduced when using Auxulin compared to conventional treatments such as insulin/water/wait. In conventional treatments, type 1 diabetics may self-administer additional insulin when blood sugar levels do not drop quickly enough, which can eventually lead to blood sugar levels dropping significantly below the desired level. However, we have not observed this with Auxulin. Auxulin causes blood sugar levels to drop rapidly, and its formulation does not independently reduce blood sugar levels. Additionally, less insulin is used when using Auxulin. It's important to note that any concerns about an individual's health should be discussed with their healthcare provider.
Auxulin's patented formulation is classified as Generally Regarded as Safe (GRAS) by the FDA, which allows it to be sold as a supplement. We made the decision to market Auxulin as a supplement rather than a drug for three main reasons:
- Lower cost to the patient
- Faster time to market
- Simpler purchasing process (no need to check with insurance to see if it's covered)
Auxulin works by addressing the underlying causes of insulin resistance. By doing so, Auxulin can be used as a supplement to traditional approaches for blood glucose management when blood sugar levels are high. It should be taken as a rescue medication whenever a diabetic reaches a high enough blood sugar level, with the level varying for each individual. To use Auxulin, take 1 tablet and 8 ounces of water per 70 pounds of body weight, in addition to your current blood glucose management. If there is no significant change to blood glucose levels within 40 minutes, additional Auxulin can be taken.