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This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
The study is looking for patients that meet the following criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PassPort(R) Transdermal Insulin Delivery System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PassPort(R) Transdermal Insulin Delivery System | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) | 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. | 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 |
| Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) | 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. | Glucose infusion rates were adjusted every 10 minutes as necessary |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients | 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. | Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicky Spratlin, M.D. | Altea Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altea Therapeutics Clinical Research Center | 387 Technology Circle, NW, Suite 100, Atlanta | Georgia | 30313 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Smith, A, Zerkel, K, Roerig, P, Mills, S, Humphries, C, Durland, R, Spratlin, V, "Transdermal Delivery of Insulin in Patients with Type 1 Diabetes," American Diabetes Association 68th Scientific Sessions, Abstract 309-OR, Diabetes 57 Supplement 1:A88, 2008. |
| Label | URL |
|---|---|
| Altea website | View source |
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Subjects stopped intermediate/long-acting insulin 48 hours prior to treatment or discontinued use of their insulin pump when they arrived for the treatment. There was a run-in period in which IV insulin lispro was administered to achieve a glucose clamp target of 100 mg/dL prior to application of the patch.
Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Patch | PassPort(r) Transdermal Insulin Delivery System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Patch | PassPort(r) Transdermal Insulin Delivery System |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) | 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. | Number of subjects completed | Posted | Nov 2010 | Mean | Standard Error | uU/mL | 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 |
|
Adverse events were collected from the time of study treatment until the last follow up visit (7 days after patch removal).
Systematic assessments of adverse events were performed throughout the study via clinical staff assessments/questions and laboratory testing. In addition, adverse events were self-reported by subjects throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transdermal Patch | PassPort(r) Transdermal Insulin Delivery System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
This was a small exploratory study to evaluate the PK, PD and tolerability of a selected Basal Insulin PassPort(r) System configuration in C-peptide negative type 1 diabetes subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pei-Ling Roerig, Sr. Manager Clinical Research, Altea Therapeutics | Altea Therapeutics | 404-835-6415 | proerig@alteatherapeutics.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients | 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. | Not Posted | Nov 2010 | Mean | Standard Deviation | TEWL (gH2O/m2/h) | Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal |
| Primary | Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) | 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. | Posted | Nov 2010 | Mean | Standard Error | mg/kg/min | Glucose infusion rates were adjusted every 10 minutes as necessary |
|
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| IV Site Pain/Swelling | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
PI is restricted from using, disclosing, presenting or publishing trial information without the prior written consent from the Sponsor.
PI is not an employee of the Sponsor but was paid to conduct the study at the Sponsor's Phase 1 Clinical Resarch Unit.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |