Trial Outcomes & Findings for Transdermal Basal Insulin Patch Study in Type 1 Diabetes (NCT NCT00519623)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

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

Results posted on

2010-12-30

Participant Flow

Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.

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.

Participant milestones

Participant milestones
Measure	Transdermal Patch PassPort(r) Transdermal Insulin Delivery System
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Transdermal Patch PassPort(r) Transdermal Insulin Delivery System
Overall Study Adverse Event	1

Baseline Characteristics

Transdermal Basal Insulin Patch Study in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transdermal Patch n=9 Participants PassPort(r) Transdermal Insulin Delivery System
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	35.4 years STANDARD_DEVIATION 10.8 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Population: Number of subjects completed

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.

Outcome measures

Outcome measures
Measure	Transdermal Patch n=8 Participants PassPort(r) Transdermal Insulin Delivery System
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)	33.0 uU/mL Standard Error 6.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transdermal Patch n=8 Participants PassPort(r) Transdermal Insulin Delivery System
Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)	4.9 mg/kg/min Standard Error 1.0

SECONDARY outcome

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Transdermal Patch

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transdermal Patch n=9 participants at risk PassPort(r) Transdermal Insulin Delivery System
Nervous system disorders Headache	22.2% 2/9 • Number of events 3 • 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.
Injury, poisoning and procedural complications IV Site Pain/Swelling	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Shoulder Pain	11.1% 1/9 • Number of events 1 • 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.

Additional Information

Pei-Ling Roerig, Sr. Manager Clinical Research, Altea Therapeutics

Altea Therapeutics

Phone: 404-835-6415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER