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112-LB: Pulsatile Insulin Treatment as a Treatment Option for Patients with Type 2 Diabetes and Stage 3 Kidney Failure

In healthy individuals, insulin is secreted by the pancreatic s-cells in a pulsatile fashion with about 10-12 pulses/hour. Loss of this pulsatility is one of the first indications of s-cell dysfunction leading to type 2 diabetes. This pulsatility of insulin secretion is considered a trigger mechanism for the regulation of hepatic gluconeogenesis and for maintaining the sensitivity of peripheral metabolic and vascular insulin receptors. Various attempts have been made over the last 30 years to use pulsatile i.v. insulin infusion therapy for treatment of diabetes and secondary complications. The purpose of this prospective randomized pilot study was to investigate the effect of once weekly PIT (2 h vs. 3 h procedures) over a period of 3 months on parameters of kidney function in patients with type 2 diabetes and chronic renal failure. Of the 22 enrolled type 2 patients, 17 performed the trial per protocol. They received a total of 10 PIT procedures. Observation parameters measured at baseline and endpoint were HbA1c, GFR, body weight, blood pressure, creatinine, nerve perception thresholds, and treatment satisfaction. At endpoint, there were no significant differences between the two groups. GFR improved by 10.8 % and creatinine decreased by 6.8 %. Stable results were seen for HbA1c, body weight and blood pressure. No changes were seen in nerve perception thresholds for any of the investigated sensory fiber qualities. The treatments were well tolerated. However, 8 treatment events of muscle cramps were reported for 5 patients during the PIT procedures. In conclusion, an improvement in kidney function and treatment satisfaction was observed after 3 months of PIT in patients with type 2 diabetes and renal failure, irrespective of the duration of the procedure. The results of this pilot trial will now be used to design an appropriate confirmatory study to investigate the effect of PIT when given in addition to standard of care treatment vs. standard of care alone. Disclosure S. Quach: None. A. Manessis: Advisory Panel; Self; Medtronic, Research Support; Self; IQVIA, Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., MannKind Corporation, Sanofi US.