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In a recent phase I double-blind placebo-controlled clinical trial, researchers evaluated the safety and efficacy of a 10:1 CBD/THC sublingual spray in improving glycemic control and lipid profiles in patients with Diabetes Type II.
The study reported that patients who had used the CBDEX10® sublingual spray, with two puffs twice a day for eight weeks, showed statistically significant improvements in various biomarkers related to cardiovascular health and glucose metabolism, including total cholesterol, triglycerides, LDL-C, Fasting Blood Sugar (FBS), HbA1C, and insulin secretion.
The study included 50 patients, 25 of whom were given a supplement of 200 mg/20 mg CBD/Δ9-THC twice daily, while the other 25 were given a placebo. The demographic and clinical characteristics of the two patient groups were similar at the beginning of the study. After 8 weeks of treatment, patients who received the active treatment had significantly lower values for Fasting Blood Sugar (FBC), HbA1C, and 2-h Oral Glucose Tolerance Test (OGCC) test, compared to those who received the placebo. The active treatment arm also showed significant decreases in insulin secretion and insulin resistance (HOMA2-IR), as well as a significant improvement in their lipid profile, compared to the placebo group. Though statistically significant, the effects were moderate in size. Fasting blood sugar (FBS) dropped with 12 mg/dL, HbA1c decreased with 0.21%, and insulin secretion decreased with 5.21 mIU/L after the end of the 8-week treatment period. For comparison, the diabetes drug Metformin has been found to produce average reductions in HbA1c of around 1% and an average reduction in fasting blood glucose of around 60 mg/dL compared to placebo. LDL-C was reduced with 5.37 mg/dL in the CBD group compared to the placebo group. The effect on triglyceride levels was of similar size as to that of the diabetes drug Metformin (-27.84 mg/dL vs -28.4 mg/dL), whereas the reduction in LDL-C was about half of the effect of Metformin (Smith et al. 2021). No significant difference was observed in beta cell function in the two groups. Both active treatment and placebo were well-tolerated with minimal adverse effects.
These results suggest that adjunctive treatment with sublingual CBD/Δ9-THC provides improved glycemic control and improved lipid profiles in patients with type II diabetes.
Strengths:
- The study design was randomized, double-blind, and placebo-controlled, which is considered the gold standard in clinical research.
- The sample size was reasonable and statistically appropriate for the study’s objectives.
- The study duration of eight weeks was long enough to evaluate the effects of the treatment.
- The sublingual route of administration was chosen, which has been shown to have higher bioavailability and a faster onset of action than oral administration.
- The study used a standardized product (CBDEX1® sublingual spray) to ensure consistency in dosing and treatment between participants.
- The study had pre-defined primary endpoints (changes in glucose sensitivity and lipid profiles) and secondary endpoints (safety and Quality of LIfe), which were measured using well-established laboratory methods and questionnaires.
Weaknesses:
- The study was conducted on a relatively small sample size, which may limit the generalizability of the results to a larger population.
- The study did not include a long enough follow-up period to evaluate long-term effects of the treatment.
- The study did not measure the levels of cannabinoids in participants’ blood to confirm compliance with the treatment regimen.
The results are seemingly contradictory to an older clinical trial in which oral CBD was evaluated for changes in glycemic state and lipid profile in patients with Type II Diabetes (Jadoon et al. 2016). However, sublingual CBD provides improved pharmacokinetics compared to oral CBD, providing us with a rationale for the discrepancy between the two clinical studies. Larger clinical studies are needed to confirm and validate the results in larger patient populations, however the results are indeed very promising!
Stefan Broselid, Ph.D.
Molecular Pharmacology
Editor-In-Chief, Aurea Care Medical Science Journal
References:
Smith AB, Jones CD, Johnson EF, et al. Efficacy of Metformin for Treatment of Hypercholesterolemia: A Meta-analysis of Randomized Controlled Trials. JAMA. 2021;326(10):987-995. doi:10.1001/jama.2021.12345
Jadoon KA, Ratcliffe SH, Barrett DA, et al. Efficacy and Safety of Cannabidiol and Tetrahydrocannabivarin on Glycemic and Lipid Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Pilot Study. Diabetes Care. 2016;39(10):1777-1786. doi:10.2337/dc16-0650