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document
Intradermal insulin infusion achieves faster insulin action than subcutaneous infusion for 3-day wear . Rapid uptake previously demonstrated by intradermal ( ID ) drug administration indicates compound delivery within the dermis may have clinical and pharmacological advantages for certain drug therapies . This study is the first clinical trial to evaluate continuous microneedle-based drug infusion , device wearability , and intradermal microneedle insulin kinetics over a multi-day ( 72 h ) wear period . This was a single center , open-label , two-period crossover study in T1DM patients on continuous subcutaneous insulin infusion ( CSII ) . Patients received treatment during interventional visits : one SC and one ID basal/bolus infusion of insulin aspart ( NovoRapid® U-100 ) administered over 3 days in a randomized order . Twenty-eight patients were randomized and exposed to trial product , and 23 completed the study . Bolus insulin infusions were given prior to standardized breakfast and lunch test meals on each of the three treatment days . Blood samples were drawn at predefined time points for measurements of insulin aspart and blood glucose in serum . The primary endpoint insulin Tmax demonstrated that ID bolus infusion was associated with a significantly shorter Tmax with statistically significantly smaller intra-subject variability , compared to SC infusion , and this difference was maintained over three treatment days . Analyses of secondary PK endpoints corresponded with the primary endpoint findings . Postprandial glycemic response was significantly less pronounced after ID bolus : For most endpoints ID vs. SC , differences were statistically significant within the 0-1.5 or 0-2 h time period . Intradermal delivery of insulin is a viable delivery route alternative providing reduced time for insulin absorption with less intra-subject variability and lower glycemic response .
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Intervention_Pharmacological
insulin infusion
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Intervention_Physical
intradermal ( ID )
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Intervention_Physical
continuous microneedle-based drug infusion
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Outcome_Physical
of insulin aspart and blood glucose in serum
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Outcome_Physical
endpoint insulin Tmax
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Outcome_Physical
significantly shorter Tmax
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Outcome_Physical
smaller intra-subject variability
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Outcome_Physical
secondary PK endpoints
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Outcome_Other
findings
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Outcome_Physical
Postprandial glycemic response
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Outcome_Other
reduced time for insulin absorption
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Outcome_Other
less intra-subject variability
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Outcome_Mental
lower glycemic response
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Participant_Condition
continuous subcutaneous insulin infusion ( CSII
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Participant_Sample-size
Twenty-eight
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Participant_Sample-size
23