Back to results

Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

Primary Purpose

Diabetes Mellitus, Insulin-Dependent

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

InsuPatch

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent focused on measuring MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18- 65 years old (including = 18 years and =65 years)
Gender: men and women
BMI: 18-35 kg/m2
Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
Subject is willing to comply with all specified follow-up evaluations -

Exclusion Criteria:

Pregnancy
Breast feeding women.
Alcohol addiction
Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)
Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.
Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L
Psychological incompetence
Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
Subjects with diminished skin integrity
Subjects with heat sensitivity
Subjects involved in or planed to participate in other studies
Subjects using other drugs therapies to control blood glucose level other than insulin.

Sites / Locations

Mills-Peninsula Health Services
Wolfson Medical Center
Haddasah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device

Control

Arm Description

Subject starts with two clamps including device use follows by a clamp without device use

Subject starts with clamps without device

Outcomes

Primary Outcome Measures

Efficacy

Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.

Safety

frequency and severity of all treatment-related adverse events until the completion of the study.

Secondary Outcome Measures

pharmacokinetics

Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test

Pharmacodynamic

Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test

Full Information

NCT ID

NCT01216618

First Posted

October 5, 2010

Last Updated

September 3, 2014

Sponsor

Insuline Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01216618

Brief Title

Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

Official Title

Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insuline Medical Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Detailed Description

Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study. The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month. There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Insulin-Dependent

Keywords

MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Experimental

Arm Description

Subject starts with two clamps including device use follows by a clamp without device use

Arm Title

Control

Arm Type

No Intervention

Arm Description

Subject starts with clamps without device

Intervention Type

Device

Intervention Name(s)

InsuPatch

Intervention Description

the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.

Primary Outcome Measure Information:

Title

Efficacy

Description

Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.

Time Frame

Up to 5 hours

Title

Safety

Description

frequency and severity of all treatment-related adverse events until the completion of the study.

Time Frame

Up to one month

Secondary Outcome Measure Information:

Title

pharmacokinetics

Description

Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test

Time Frame

Up to 5 hours

Title

Pharmacodynamic

Description

Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test

Time Frame

Up to 5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18- 65 years old (including = 18 years and =65 years) Gender: men and women BMI: 18-35 kg/m2 Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart. Diabetic subjects with HbA1c values below 9.5% (including 9.5%). Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed Subject is willing to comply with all specified follow-up evaluations - Exclusion Criteria: Pregnancy Breast feeding women. Alcohol addiction Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L Psychological incompetence Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant. Subjects with diminished skin integrity Subjects with heat sensitivity Subjects involved in or planed to participate in other studies Subjects using other drugs therapies to control blood glucose level other than insulin.

Facility Information:

Facility Name

Mills-Peninsula Health Services

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Wolfson Medical Center

City

Holon

Country

Israel

Facility Name

Haddasah Medical Organization

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Links:

URL

http://www.insuline-medical.com

Description

Sponsor's Official web site

Learn more about this trial

Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

We'll reach out to this number within 24 hrs