title: Randomized, double-blind, placebo-controlled, clinical study on the effect of Diabetinol(®) on glycemic control of subjects with impaired fasting glucose.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: KGK Synergize Inc., London, ON, Canada.
authors.forename: Malkanthi
authors.initials: M
authors.lastname: Evans
authors.affiliation: SIBR Research Inc., Bradenton, FL, USA.
authors.forename: William V
authors.initials: WV
authors.lastname: Judy
authors.affiliation: London Health Sciences Center, University of Western Ontario, London, ON, Canada.
authors.forename: Dale
authors.initials: D
authors.lastname: Wilson
authors.affiliation: Princeton Longevity Center, Princeton, NJ, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Rumberger
authors.affiliation: KGK Synergize Inc., London, ON, Canada.
authors.forename: Najla
authors.initials: N
authors.lastname: Guthrie
keywords: adjunctive therapy; citrus flavonoids; diabetes; hypercholesterolemia; hyperlipidemia; insulin; limonoids