a phase i randomized, double-blind, placebo-controlled study on efficacy and safety profile of a sublingually administered cannabidiol /delta 9-tetrahydrocannabidiol (10: 1) regimen in diabetes type 2 patients

The current study aimed to evaluate the safety profile and efficacy of a cannabis-based sublingual spray, cbdex10® (containing 100 µg cannabidiol and 10 µg δ9-tetrahydrocannabinol per puff; cbd/δ9-thc 10:1), in improving lipid profile and glycemic state of the diabetic patients. fifty diabetic patients were randomly allocated to the treatment (n = 25; receiving two puffs of cbdex10® twice daily) or the control groups (n = 25; receiving two puffs of placebo). the primary endpoint of the study was to evaluate the efficacy of the cbdex10® adjunctive therapy in improving the lipid profile and glycemic state of diabetic patients; the secondary endpoint was to assess the safety profile and tolerability of the spray. a statistically significant decline in total cholesterol [estimated treatment difference (etd) = −19.73 mg/dl; p < 0.05], triglyceride (etd = −27.84 mg/dl; p < 0.01), ldl-c (etd = −5.37 mg/dl; p < 0.01), fbs (etd = −12 mg/dl; p < 0.01), hb a1c (etd = −0.21 mg/dl; p < 0.01) and insulin secretion (etd = -5.21 miu/l; p < 0.01) was observable in the patients treated with cbdex10® at the end of the 8-week treatment period. regarding safety, the mentioned adjunctive regimen was well, and there were no serious or severe adverse effects. overall, cbdex1® sublingual spray could be a new therapeutic agent for lipid and glycemic control in diabetic patients.