Syqe Medical launches clinical trial of cannabis-based treatment for diabetes patients

The company is looking to recruit 192 patients from up to 55 clinics in six participating countries – Australia, Israel, Canada, Poland, the Czech Republic and Germany – by the end of June 2025.

Adults aged 18 to 75 with a confirmed diagnosis of diabetes and neuropathic pain in feet will be considered for inclusion in the double-blind, randomised, placebo-controlled study, which will be led in Australia by the NICM Health Research Institute at Western Sydney University.

Australia and New Zealand College of Cannabinoid Practitioners (ANZCCP) co-founder and president Dr Orit Holtzman will be the principal investigator.

The trial will evaluate the efficacy, safety, tolerability and pharmacokinetics of inhaled THC at 0.25mg, 0.5mg and 1mg doses administered via the SyqeAir inhaler three times daily over 15 weeks compared to a placebo.

The TGA-approved device allows patients to receive a precise dose of THC with a predictable and consistent effect, enabling prescribers to provide an inhalation-based, full-spectrum flower treatment in a standardised manner.

Researchers will look to identify changes in pain characteristics as well as severity and intensity, along with changes in sleep, quality of life and overall well-being.

Participants must agree not to drive or operate heavy machinery during the treatment period and those of reproductive age must agree to use ‘highly effective’ contraception.

Among those not eligible to take part are patients with a history of alcohol/substance abuse or chronic use of opioids, along with breast-feeding and pregnant women.

Titration, tests and data collection will take place via 14 on-site visits and six telephone consults over a total period of five-and-a-half months.

While patients cannot drive during the 15-week treatment part of the study due to its THC component, all transport costs to and from appointments will be covered by Syqe.

Associate Professor Mike Armour from NICM said this was a challenge for medicinal cannabis trials involving THC and that Syqe’s was the best approach possible given the current drug-driving framework.

Dr Holtzman added: “In the current Australian landscape, where the distinction between non-medical and medical cannabis use is increasingly blurred – often favouring higher-THC concentrations – Syqe’s commitment to pursuing evidence-based, accurate dosing and establishing a therapeutic window with optimal effect, minimal side effects and unparalleled safety is noteworthy.”

DPNP impacts 6% to 34% of patients with diabetes. Symptoms include burning, shooting, lancinating pain and tingling, starting in the feet and often getting worse at night.

It affects daily functioning and sleep in sufferers, often resulting in anxiety and depression and is associated with diminished quality of life.

Syqe said side effects can hamper current pain management strategies, meaning the condition represents an unmet medical need.