25-PUB: Exploratory Post Hoc Analysis of Effect of GlucoLo Plus on Renal Function in the GLEEN Randomized Trial—Efficacy and Safety of GlucoLo Plus in Type 2 Diabetes Management

Introduction & Objective: GlucoLo Plus is a Complementary and Alternative Medicine (CAM) that has shown clinically significant HbA1c reduction of 0.843% in the GLEEN trial, a previously reported double-blind randomized placebo-controlled trial that evaluated the efficacy and safety of daily GlucoLo Plus. The renal data will now be presented.

Methods: The GLEEN Study was composed of 60 individuals with type 2 diabetes with a mean HbA1c 6.98% [52.8 mmol/mol], mean age 67.3 years [SD 9.5], 26 [43%] women, mean diabetes duration was 3.2 years, and mean body mass index 27.9 kg/m². Participants were randomly assigned to GlucoLo Plus (n=32 [53%]), or placebo (n=28 [47%]). The renal safety was evaluated by measuring the serum Creatinine and urinary Albumine-to-Creatinine ratio (uACR) and by calculating the estimated Glomerular Filtration Rate (eGFR) with the Modification of Diet in Renal Disease equation (MDRD) at randomization and at the end of the trial.

Results: At the end of the 12-week long GLEEN trial, the GlucoLo Plus arm had a 0.77 % creatinine increase (85.47 to 86.13 µmol/L) and a 0.85% estimated eGFR decrease (76.38 to 75.73 ml/min/1.73m²) while the placebo group had a 1.77% creatinine increase (78.5 to 79.89 µmol/L) and a 0.65% eGFR decrease (81.4 to 80.8 ml/min/1.73m²). The trial participants randomized to receive GlucoLo Plus had a 38% uACR reduction (3.70 to 2.267 mg/mmol) while the placebo group had a 15.26% increase in uACR (2.01 to 2.32 mg/mmol).

Conclusion: The results of this post-hoc analysis of the GLEEN trial suggests that GlucoLo Plus is safe regarding renal function evaluated by serum creatinine and calculated eGFR. This analysis also revealed a potential benefit of GlucoLo Plus regarding albuminuria, but bigger and longer trial would be warranted to confirm these findings.