Transdermal Basal Insulin Patch Study in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00519623|
Recruitment Status : Completed
First Posted : August 22, 2007
Results First Posted : December 30, 2010
Last Update Posted : December 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Other: PassPort(R) Transdermal Insulin Delivery System||Phase 1 Phase 2|
The study is looking for patients that meet the following criteria:
- Duration of type 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
- Body Mass Index (BMI) 18.5 - 32
- No advanced diabetes complications
- Not pregnant or breast feeding
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
|Experimental: PassPort(R) Transdermal Insulin Delivery System||
Other: PassPort(R) Transdermal Insulin Delivery System
The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
- Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) [ Time Frame: Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours ]Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.
- Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) [ Time Frame: Glucose infusion rates were adjusted every 10 minutes as necessary ]Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.
- Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients [ Time Frame: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal ]Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519623
|United States, Georgia|
|Altea Therapeutics Clinical Research Center|
|387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States, 30313|
|Principal Investigator:||Vicky Spratlin, M.D.||Altea Therapeutics|