NCT00519623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

December 30, 2010

Completed
Last Updated

December 30, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

August 2, 2007

Results QC Date

December 3, 2010

Last Update Submit

December 3, 2010

Conditions

Type 1 Diabetes

Keywords

diabetesinsulinblood sugartype 1 diabetesinsulin dependent diabetestransdermal

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients

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

Study Arms (1)

PassPort(R) Transdermal Insulin Delivery System

EXPERIMENTAL
Other: PassPort(R) Transdermal Insulin Delivery System

Interventions

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.

PassPort(R) Transdermal Insulin Delivery System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altea Therapeutics Clinical Research Center

387 Technology Circle, NW, Suite 100, Atlanta, Georgia, 30313, United States

Location

Related Publications (1)

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Limitations and Caveats

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.

Results Point of Contact

Title
Pei-Ling Roerig, Sr. Manager Clinical Research, Altea Therapeutics
Organization
Altea Therapeutics
proerig@alteatherapeutics.com
404-835-6415

Study Officials

  • Vicky Spratlin, M.D.

    Altea Therapeutics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 22, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

December 30, 2010

Results First Posted

December 30, 2010

Record last verified: 2010-12

Locations

US(1)