Transdermal Basal Insulin Patch Study in Type 1 Diabetes
This study has been completed.
Sponsor:
Altea Therapeutics
Information provided by:
Altea Therapeutics
ClinicalTrials.gov Identifier:
NCT00519623
First received: August 2, 2007
Last updated: December 3, 2010
Last verified: December 2010
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Purpose
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Other: PassPort(R) Transdermal Insulin Delivery System |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
Further study details as provided by Altea Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 9 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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
- Non-smoker
- No advanced diabetes complications
- Not pregnant or breast feeding
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519623
Locations
| United States, Georgia | |
| Altea Therapeutics Clinical Research Center | |
| 387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States, 30313 | |
Sponsors and Collaborators
Altea Therapeutics
Investigators
| Principal Investigator: | Vicky Spratlin, M.D. | Altea Therapeutics |
More Information
Publications:
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.
| Responsible Party: | Alan Smith, Vice President, Product Development, Clinical R&D, and Project Management, Altea Therapeutics Corporation |
| ClinicalTrials.gov Identifier: | NCT00519623 History of Changes |
| Other Study ID Numbers: | IN2007001 |
| Study First Received: | August 2, 2007 |
| Results First Received: | December 3, 2010 |
| Last Updated: | December 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Altea Therapeutics:
|
diabetes insulin blood sugar |
type 1 diabetes insulin dependent diabetes transdermal |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013