A 26 week study to evaluate safety and efficacy of MICROBEFIBER on Pre-Diabetes and Type II Diabetes Mellitus on patients either naïve to treatment or on stable regimen for the past 12 weeks.

Introduction 

Type II diabetes mellitus is a growing health concern in the US and throughout the world. Projections show a continued increase in the incidence of this disease and the associated significant complications. There is recognition that prevention and effective disease modifying therapies are needed in spite of the current available medications. The goal of diabetes treatment is to have an effective lowering of Hemoglobin A1c while not causing weight gain or inducing hypoglycemia.

Summary of Study Design

MFPD-T2DM-003 protocol was a pilot study to evaluate the efficacy of MICROBEFIBER administered 3 times daily over 24 weeks in patients with pre-diabetes and Type 2 diabetes mellitus (T2DM) drug naïve or as add on therapy in patients on a stable drug regimen. 

Multiple parameters were evaluated including change in Hemoglobin A1c, effect on body weight, waist circumference and other exploratory end points. The intent was to determine the ideal subject population for future clinical trials.

We felt it was important to hold MICROBEFIBER to the rigors of other clinical trials to allow for a comparison to the pharmaceutical agents currently available for the treatment of Type 2 DM. The duration needed to be sufficient to see a difference in the treatment group as compared to the control group. Both the treatment and control group were randomly selected and each was given intensive dietary education and regular monitoring and accountability. 

There were 2 categories of patients:

Pre-diabetes or controlled diabetics with A1c <7.0

Diabetics with a baseline A1c > 7.0 ranging as high as 11.2

The demographics are summarized as males 65%, females 35% average age 58 years old with average A1c 8.3 with 13 years average duration of diabetes. 

Summary of Results

        There were a total of 42 patients randomized to either control group or active MICROBEFIBER treatment group. Both groups received structured dietary instruction based on ADA guidelines and regular re-enforcement and accountability. Subjects kept diaries to determine compliance with carbohydrate intake.

        There were 23 subjects with a baseline A1c > 7 randomized to MICROBEFIBER and 5 subjects with A1c > 7 randomized to the control group. Clinical trials in type 2 DM evaluate therapies by measuring the proportion of patients achieving a clinically relevant composite result of a Hemoglobin A1c < 7 without causing weigh gain or hypoglycemia.

          Of the 23 MICROBEFIBER subjects, 6 achieved an A1c < 7 or 26%. In contrast none of the control group reached A1c < 7. The majority of the subjects in the MICROBEFIBER (15/23 or 65.2%) had a reduction A1c with an average decrease of 0.97 which is comparable or better than what is expected to be achieved by use of pharmaceuticals (see table 1). The average decline in A1c all subjects in the MICROBEFIBER treatment group was 0.43 as compared to an actual increase of 0.28 in the control group.

        In addition to a robust reduction in A1c in the MICROBEFIBER treatment group, there was also noted to be significant weight loss (16/23 or 70%). This was an average weight loss of 5.8lbs. A measurement of the waist circumference also was notable with 19/23 having a decrease or no change. This amounts to an average loss of 0.86 inches. The composite of either weight loss or waist circumference reduction was 19/23 or 82.6%. In the control group there was no discernable change in either weight or waist circumference.

  There was no clear signal for change in A1c in the group of subjects with A1c < 7.0 treated with MICROBEFIBER. However, 10/12 or 83.3% lost weight with the average weight loss of 6.4lbs. Waist circumference also improved significantly in 10/12 or 83.3% of this group with an average decrease of 1.6 inches. 

Discussion

      Subjects with a baseline A1c > 7.0 treated with MICROBEFIBER achieved comparable or superior results when pharmaceuticals currently being used in the treatment of Type II DM. There was good weight reduction and none of the MICROBEFIBER patients had any incidence of hypoglycemia. When taking into account the composite of the proportion achieved goal of A1c < 7, no weight gain and no hypoglycemia, MICROBEFIBER has a very favorable profile as summarized in the table 1. 

There are no clear strategies on how to utilize known medications in pre-diabetics (A1c < 7). The approached used in the medical community focuses on lifestyle modification. It was clear that the MICROBEFIBER treated group had a notable improvement in body weight and weight circumference. Ongoing research recognizes that modification of weight and decreasing central obesity has a beneficial effect on cytokines and other markers possibly correlating to improvement in health outcomes. 

Further evaluation into other exploratory end points will be undertaken. A larger scale IRB approved and monitored clinical trial is crucial for MICROBEFIBER in order to obtain data that will be statically significant allowing for publication and promotion.