FAQs

Why is Auxulin over the counter instead of a prescription ?
This is because Auxulin's active ingredients are naturally occurring substances on the Generally Recognized as Safe (GRAS) by the FDA. We chose to bring Auxulin to market as a supplement instead of a drug for 3 main reasons:

 -Decreased cost to patients

- Decreased time to market

- Decreased complexity in purchasing (no need to call your insurance provider to see if it's on their formulary)

 

How does Auxulin work?

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.
- Read more here

Will Auxulin work for type 2 diabetics?

While we have only done limited testing for type 2 diabetics, we believe Auxulin should reduce the magnitude and duration of events hyperglycemic events, especially for those events who use insulin.

Aren’t sodium salts bad for diabetics?

Experimental evidence suggests that more sodium salts are not necessarily bad for diabetics. For example, a recent article describing a prospective cohort study looking at the correlation between sodium and outcomes in events diabetic patients concluded that: “lower 24 hour 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, which yields 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 (early stage renal disease), such that individuals with the lowest sodium excretion had the highest cumulative incidence of ESRD.” 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 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)
Can I use Auxulin to replace my basal or bolus insulin?

No, Auxulin is meant to reduce your insulin resistance, caused by dehydration and hyponatremia, and augment the speed with which your insulin works.

Can Auxulin treat diabetic ketoacidosis (DKA)?

Auxulin’s initial concept was an attempt to develop a convenient and affordable product that would be taken to prevent diabetic ketoacidosis. 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 seek immediate emergency treatment.

Does Auxulin work with every insulin ?

Yes

Is this approved by the FDA?

Auxulin is not regulated as a drug and thus is not approved by the FDA. All 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, and petition the FDA for approval of qualified health claims.

Will Auxulin work for type 2 diabetics?

While we have only done limited testing for type 2 diabetics, we believe Auxulin should reduce the magnitude and duration of their hyperglycemic events, especially if they use external sources of insulin, such as injection.

How often can I take Auxulin ?

Auxulin should be used as a rescue medication for extremely high blood sugar levels, and at most no more than 2 doses of up to three tablets, based on body weight, should be taken per day. 

If I’m pregnant can I take Auxulin?

Ask your doctor or primary care provider as this has not yet been evaluated. 

How many Auxulin tablets can I take in a day ?

The maximum we’d recommend is 6 tablets per day.

Can Auxulin cause rebound hyperglycemia?

We believe that using Auxulin significantly reduces the risk compared to the conventional treatment of taking insulin, drinking water, and waiting. In the conventional treatment, when blood sugar levels do not drop quickly enough, type 1 diabetics may self-administer additional insulin, which can lead to blood sugar levels dropping significantly below the desired level. However, we have not observed this with Auxulin. With Auxulin, less insulin is needed as blood sugar levels drop rapidly, and Auxulin's formulation does not independently reduce blood sugar levels.

Tell me more about this informal “open label” clinical study results:
  • 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 diabetic 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 (using a 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 Auxulin, 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 of Auxulin 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.

Can Auxulin drop my hemoglobin A1C percentage?

Although we did not conduct a robust clinical trial to test Auxulin's impact on hemoglobin A1C percentages, we measured the A1C percentage levels of Tommy and Gary (the founders) over a period of several months. They consistently took what would become Auxulin and, over 6 month period, they experienced an average A1C percentage reduction of nearly 0.1 percent per month. The A1C percentage for both Tommy and Gary have remained at life long lows.