Pharmacokinetic and Pharmacodynamic Effects of a SC Infusion of Insulin Lispro by a Disposable Basal Insulin Pump in Healthy Volunteers

Rave, Klaus; Heinemann, Lutz; Gravesen, Peter
June 2007
Diabetes;Jun2007 Supplement 1, Vol. 56, pA120
Academic Journal
Basal infusion of insulin with a constant rate over a period of at least 3 days is an attractive option for patients with type 2 diabetes. In comparison to SC injection of long-acting insulin analogues this should led to a more constant metabolic effect. A novel disposable Microfluidic Elastomer Patch Pump (MEPP) was developed to allow high accurate and constant insulin infusion. By means of the glucose clamp technique (target blood glucose 4.5 mmol/l) we measured the pharmacokinetic and pharmacodynamic responses to a continuous SC infusion of insulin lispro (IL) either applied via MEPP or by a commercially available insulin pump (Accu-Chek Spirit, A-CS, Roche Diagnostics). This open-labelled, cross-over study enrolled 8 healthy male volunteers (mean age 36 years (range 30-44); BM126.7 kg/m2 (23.0-29.9)). IL was infused at a rate of 2 U of per h for 24 h, using the MEPP for 3 out of 4 experiments performed in each volunteer;, A-CS was used during the other experiment. Blood samples were taken in regular intervals for specific measurement of serum IL levels. Twenty seven individual MEPPs were employed during the 24 glucose-clamps, among which 21 constantly delivered IL and 6 failed. Taking data from the successful experiments only, total serum insulin lispro AUC (AUC-INS0-24h 44.7±11.7 vs 38.8±7.5 min/ml (mean±SD)), fractional levels (AUC-INS0-6h 7.64±2.5 vs 7.3±1.4 mU.min/ml), peak serum IL levels (INSmax 43.1±11:7 vs 36.4±6.0 µU/ml) and time to peak levels (T- INSmax 853±253 vs 559±308 min) were comparable niter infusion with MEPP or A-CS. Likewise, glucose infusion rates were similar during infusion of IL via MEPP or A-CS (AUC-GIR0-24h 5533±2233 vs 5499±1865 mg/kg). Mean weight difference of insulin pumps after 24 h of insulin pumping was 0.63±0.07 g for MEPP and 0.49±0.01 g for A-CS, which is well the theoretical amount of pumped insulin. Analysis of failing MEPPs revealed that remains from the production process obstructing the flow capillary were responsible for pump failures. In summary, insulin infusion by means of a disposable pump result in a PK/PD response comparable to that observed with a commercially available pump. Given that a more reliable performance of this functional model is possible, this Microfluidic Elastomer Patch Pump is an attractive alternative to conventional insulin pumps.


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