Type 1 DiabetesPhase 1/2NCT00519623

Transdermal Basal Insulin Patch Study in Type 1 Diabetes

A Phase 1/2 study testing PassPort(R) Transdermal Insulin Delivery System in people with Type 1 Diabetes, run by Altea Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: PassPort(R) Transdermal Insulin Delivery System
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Dec 2007
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Altea Therapeutics Clinical Research Center
387 Technology Circle, NW, Suite 100, Atlanta, Georgia, 30313

Other trials in United States

About this study

Official title: Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients

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

Read the 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

Conditions: Type 1 Diabetes
Being tested: PassPort(R) Transdermal Insulin Delivery System
Keywords: diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PassPort(R) Transdermal Insulin Delivery SystemOther
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.

Study groups in NCT00519623
Study group	Role	What they receive
PassPort(R) Transdermal Insulin Delivery System	Experimental	Not described Receives: Other: PassPort(R) Transdermal Insulin Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Glucose infusion rates were adjusted every 10 minutes as necessary

Secondary outcomes (1)

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.
Measured: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Dec 2007

First posted22 Aug 2007 (estimated)
Study startAug 2007
Primary completionNov 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00519623
Sponsor's protocol ID: IN2007001
Status last verified: Dec 2010
First submitted: 2 Aug 2007
Last updated: 30 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
ClinicalTrials.gov ID: NCT00519623
Acronym / sponsor ID: IN2007001
Conditions: Type 1 Diabetes
Keywords: diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Altea TherapeuticsIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Nov 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 22 Aug 2007 (estimated)
Results: Posted 30 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PassPort(R) Transdermal Insulin Delivery System	Experimental	Other: PassPort(R) Transdermal Insulin Delivery System

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PassPort(R) Transdermal Insulin Delivery SystemThe 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.	Other	PassPort(R) Transdermal Insulin Delivery System

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 30 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transdermal Patch	9	8

Primary outcome: 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. Mean (Standard Error). Unit: uU/mL

Measure	Transdermal Patch n = 8
Value	33.0 (6.3)

Population analysed: Number of subjects completed

Primary outcome: 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. Mean (Standard Error). Unit: mg/kg/min

Measure	Transdermal Patch n = 8
Value	4.9 (1.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of study treatment until the last follow up visit (7 days after patch removal).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transdermal Patch	0 of 9 (0%)	4 of 9 (44.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationSmith, 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.
Altea websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vicky Spratlin, M.D. principal investigator

Altea Therapeutics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PassPort(R) Transdermal Insulin Delivery System in people with Type 1 Diabetes, run by Altea Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00519623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2010; AzTrials last refreshed its copy on 27 Oct 2026.