Randomized, double-blind, placebo-controlled, clinical study on the effect of Diabetinol(®) on glycemic control of subjects with impaired fasting glucose

Malkanthi Evans; William V Judy; Dale Wilson; John A Rumberger; Najla Guthrie

doi:10.2147/DMSO.S79450

Randomized, double-blind, placebo-controlled, clinical study on the effect of Diabetinol(®) on glycemic control of subjects with impaired fasting glucose

Diabetes Metab Syndr Obes. 2015 Jun 25:8:275-86. doi: 10.2147/DMSO.S79450. eCollection 2015.

Authors

Malkanthi Evans¹, William V Judy², Dale Wilson³, John A Rumberger⁴, Najla Guthrie¹

Affiliations

¹ KGK Synergize Inc., London, ON, Canada.
² SIBR Research Inc., Bradenton, FL, USA.
³ London Health Sciences Center, University of Western Ontario, London, ON, Canada.
⁴ Princeton Longevity Center, Princeton, NJ, USA.

Abstract

Background: This study investigated the efficacy of Diabetinol(®) in people with diabetes on medication but not meeting the American Association of Clinical Endocrinologists and American Diabetes Association glycemic, blood pressure, and lipid targets.

Subjects and methods: Fifty subjects, aged 18-75 years, with fasting blood glucose ≤15.4 mmol/L, hemoglobin A1c levels ≤12%, and a body mass index between 25 and 40 kg/m(2), were enrolled in a 24-week, randomized, double-blind, placebo-controlled, parallel study. Diabetinol(®) or placebo was administered as 2×525 mg capsules/day.

Results: In the Diabetinol(®) group, 14.3% versus 0% in the placebo group, 33.3% versus 15.4% in placebo, 20.0% versus 12.5% in placebo, and 83.3% versus 60% in placebo achieved the American Association of Clinical Endocrinologists and American Diabetes Association targets for hemoglobin A1c, low-density lipoprotein, total cholesterol, and systolic blood pressure, respectively. There was no difference in the maximum concentration (Cmax) of serum glucose or area under the curve (AUC)0-240 minutes. The time to Cmax was longer for participants on Diabetinol(®) than placebo group at week 12 (P=0.01). Fasting blood glucose increased from baseline to week 24 in both groups; however, this increase was 14.3 mg/dL lower in the Diabetinol(®) group versus placebo. The Diabetinol(®) group showed an increase of 5.53 mg/dL in fasting insulin at week 12 (P=0.09) and 3.2 mg/dL at week 24 (P=0.41) over and above the placebo group. A decrease of 1.5% in total cholesterol, 5.8% in low-density lipoprotein, and a 1.6% increase in high-density lipoprotein concentrations were seen in the Diabetinol(®) group. Diabetinol(®) improved 6-month oral glucose tolerance test and 2-hour postprandial glucose profiles in participants between 40 and 60 years of age.

Conclusion: The current study suggests a role for Diabetinol(®) as an adjunctive therapy for glycemic maintenance and for decreasing the risk of diabetes-associated comorbidities in type 2 diabetic patients on conventional therapies.

Keywords: adjunctive therapy; citrus flavonoids; diabetes; hypercholesterolemia; hyperlipidemia; insulin; limonoids.