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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216618
• Other study ID #: G080106/A
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2010
• Last updated: September 3, 2014
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Insuline Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18- 65 years old (including = 18 years and =65 years)

2. Gender: men and women

3. BMI: 18-35 kg/m2

4. Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.

5. Diabetic subjects with HbA1c values below 9.5% (including 9.5%).

6. Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed

7. Subject is willing to comply with all specified follow-up evaluations -

Exclusion Criteria:

1. Pregnancy

2. Breast feeding women.

3. Alcohol addiction

4. Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date

5. Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study

6. Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)

7. Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.

8. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.

9. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L

10. Psychological incompetence

11. Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.

12. Subjects with diminished skin integrity

13. Subjects with heat sensitivity

14. Subjects involved in or planed to participate in other studies

15. Subjects using other drugs therapies to control blood glucose level other than insulin.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon
Israel	Haddasah Medical Organization	Jerusalem
United States	Mills-Peninsula Health Services	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Insuline Medical Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 hours	No
Primary	Safety	frequency and severity of all treatment-related adverse events until the completion of the study.	Up to one month	Yes
Secondary	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	Up to 5 hours	No
Secondary	Pharmacodynamic	Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test	Up to 5 hours	No

External Links

•   Sponsor's Official web site