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
| Author | Shima Afshar | en |
| Author | Shayesteh Khalili | en |
| Author | Gholamreza Amin | en |
| Author | Mohammad Abbasinazari | en |
| Orcid | Gholamreza Amin [0000-0002-2812-3040] | en |
| Issued Date | 2022-12-31 | en |
| Abstract | 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. | en |
| DOI | https://doi.org/10.5812/ijpr-132647 | en |
| Keyword | Cannabidiol/Delta 9-tetrahydrocannabi | en |
| Keyword | Clinical Trial | en |
| Keyword | Diabetes Melitus | en |
| Keyword | HgA1C | en |
| Publisher | Brieflands | en |
| Title | 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 | en |
| Type | Research Article | en |
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