Phase 2
Completed N=9
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Source: ClinicalTrials.gov NCT00519623 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) — 33.0 uU/mL
Summary
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) |
33.0 | — |
| PRIMARY Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) |
4.9 | — |
| SECONDARY Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients |
— | — |
Eligibility Criteria
Inclusion Criteria
- Duration of type 1 diabetes greater than or equal to 10 years
- HbA1c less than or equal to 9.0%
- C-peptide negative
- Ages 18 - 65, male or female
- BMI 18.5 - 32
- Non- smoker
- No advance diabetes complications
- Not pregnant or breast feeding
Exclusion Criteria
- Arm or leg rashes, open wounds, or skin conditions
- Psychiatric disorders
- Participation in a clinical research trial in last 3 months
- Clinically significant acute illness
Data sourced from ClinicalTrials.gov (NCT00519623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.