MedDataX Logo

Transdermal Basal Insulin Patch Study in Type 1 Diabetes

NCT ID: NCT00519623

Last Updated: 2010-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

diabetes insulin blood sugar type 1 diabetes insulin dependent diabetes transdermal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PassPort(R) Transdermal Insulin Delivery System

Group Type EXPERIMENTAL

PassPort(R) Transdermal Insulin Delivery System

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Altea Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Altea Therapeutics Corporation

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vicky Spratlin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Altea Therapeutics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Altea Therapeutics Clinical Research Center

387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

Related Links

Access external resources that provide additional context or updates about the study.

http://www.alteatherapeutics.com

Altea website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IN2007001

Identifier Type: -

Identifier Source: org_study_id