Background and Aims

DiaGone™ is an endoscopic device which utilizes precisely controlled laser technology to target the duodenal submucosal neural plexi with the aim of improving glucose control by modulating the gastrointestinal neurohumoral axis.

Methods

Nine subjects (5 males) with obesity (BMI 34.0±4.6 kg/m²) and type 2 diabetes mellitus (T2DM) insufficiently controlled on metformin were included in this first-in-human trial in order to assess the efficacy and safety of DiaGone™. Biochemical and anthropometric parameters were assessed at baseline and 3 and 6 months after the procedure and a standard liquid meal test was performed at baseline and 3 months after the procedure.

Results

DiaGone™ significantly decreased fasting glucose (12.4±3.5 vs. 9.5±2.0 vs. 9.7±2.7 mmol/l for baseline vs. 3 vs. 6 months, p<0.01) and HbA_1C (78.3±13.3 vs. 64.9±6.4 vs. 64.8±7.1 mmol/mol, p<0.01) as well as. Glucose AUC during the 150 min meal test 3 months after the procedure showed a reduction of 20% from baseline (43,435 vs. 34,096, p<0.01). No significant changes were observed in AUC for insulin. No adverse events related to the procedure or significant changes in weight were reported throughout the 6-month period.

Conclusions

These pilot results suggest that endoscopic duodenal submucosal laser ablation using the DiaGone™ device is associated with improvements in both baseline and postprandial glycemia as well as HbA_1C with no significant changes in insulin levels or body weight while having a favorable safety and tolerability profile.

Supported by MHCZ-DRO („Institute for Clinical and Experimental Medicine – IKEM, IN 00023001“) and RVO VFN64165.

Background and Aims

The aim of our study was to verify the adherence to metformin treatment by determining its serum levels during a routine outpatient control.

Methods

208 patients with type 2 diabetes mellitus from a single tertiary diabetes centre (aged 68.0±8.9 years, HbA_1C 56.0±13.4 mmol/mol) using standard or XR (sustained release) form of metformin were included in the study. Blood sampling for metformin was performed during a regular outpatient visit. Hydrophilic interaction chromatography (HILIC) and high resolution mass spectrometry (Q Exactive Plus instrumentation) were used to quantify metformin levels.

Results

In the whole group, mean metformin levels reached 1480.4±1110.0 ng/ml, while not significantly differing between the standard and XR form. Inadequate values ​​(<100 ng/ml) were measured in 6.7% of subjects, whereas in 2.4% metformin was not detected at all. The presence of subtherapeutic levels was not affected by the administration of XR form (6.3 vs. 8.3% for standard vs. XR, n.s.). In 11.0% of patients, metformin was part of a combination preparation with another antidiabetic drug, with none of the subjects showing sub-therapeutic levels. No difference between patients with optimal and sub-therapeutic metformin values was seen in fasting glucose (8.1±2.6 vs. 8.7±3.6 mmol/l, n.s), HbA_1C (55.6±13.3 vs. 58.4±14.8 mmol/mol, n.s.) or BMI (30.6±4.7 vs. 31.3±4.4 kg/m²).

Conclusions

In a tertiary diabetes centre the compliance with metformin treatment was greater than 93% and increased with the use of combination preparations, while the XR form was not associated with a higher adherence rate.

Acknowledgements: MZ CR–RVO (IKEM, IC 00023001) and RVO VFN64165.