Background and Aims: Diabetes is globally increasing in prevalence and patients are constantly on the lookout for Complementary and Alternative Medicines (CAM) that are safe and efficacious including biologically-based practices such as vitamins and dietary supplements.
Methods: This double-blind randomised placebo-controlled trial evaluated the effects of daily GlucoLo Plus, a newly formulated biologically-based CAM for diabetes type 2 management. The primary outcome was to evaluate the effect of GlucoLo Plus on HbA1c and the secondary outcomes were to assess its effect on fasting glycemia, lipid profile, weight and assess its safety profile.
Results: Of 64 individuals assessed for eligibility, 60 (mean HbA1c 6.98% [52.8 mmol/mol], mean age 67.3 years [SD 9.5], 26 [43%] women, mean diabetes duration 3.2 years, and mean body mass index 27.9 kg/m2) were randomly assigned to GlucoLo Plus (n=32 [53%]) , or placebo (n=28 [47%]) . At 12 weeks, GlucoLo Plus decreased HBA1c by 0.843% (P=0.0121) while placebo reduced it by 0.132% (p = 0.5951) . GlucoLo Plus was also associated with non-significant reduction in fasting glycemia, total cholesterol, triglyceride, and LDL-cholesterol. GlucoLo Plus arm had a mean 1.84 lbs weight loss while the placebo arm had a 0.21 lbs weight gain. The most frequent adverse events with GlucoLo Plus were mild and transient gastrointestinal events including nausea (9.3% vs. 3.5%) and dyspepsia (15.6% vs. 10.7%) .
Conclusion: GlucoLo Plus significantly lowered HbA1c and had positive effect on bodyweight, fasting glycemia, LDL-cholesterol and had a minimal side effect profile. These results suggest that GlucoLo Plus could be an alternative and adjunct to type 2 diabetes management in people who are reluctant to initiate or add new antidiabetic agents.
A.R.Zarruk: Advisory Panel; Amgen Canada, AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eisai Inc., Eli Lilly and Company, HLS Therapeutics Inc., Novo Nordisk Canada Inc., Sanofi, Takeda Canada, Valeant Pharmaceuticals, Other Relationship; Groupe Nature Pharma, Research Support; Abbott Diabetes, Novo Nordisk Canada Inc., Orimed Pharma, Speaker's Bureau; Abbott, Abbott Diabetes, Amgen Canada, AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Mylan N.V., Novo Nordisk Canada Inc., Orimex Pharma, Sanofi, Takeda Canada, Valeant Pharmaceuticals, Viatris Inc.
Groupe Nature Pharma