A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle (MicronJet)

An Open Label Study in Healthy Volunteers and Diabetes Mellitus Type II Subjects to Determine the Safety, Pharmacokinetics and Pharmacodynamics Profile of Insulin Injected by the MicronJet Device

The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.

Study Overview

• Status: Completed
• Conditions: Intradermal Injections
• Intervention / Treatment: Device: MicronJet; Device: MicronJet

Detailed Description

Administration of insulin to the skin has many potential advantages including improved kinetics and reduced pain. Today, insulin is injected to the SQ space, using, in most cases, various devices incorporating standard metal needles and usually causing considerable pain and discomfort to the patients. NanoPass has developed a microneedle based needle substitute for intradermal injections. This device requires minimal expertise and is expected to cause minimal or no pain during injections.

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of insulin Novorapid® (Novo Nordisk) injected via the MicronJet device intradermally, to a conventional needle injected to the SQ space.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

A. Healthy volunteers

Inclusion Criteria:

1. Men ranging in age from 18-40 years.
2. In good general health as determined by medical history, physical examination, ECG and clinical laboratory tests obtained with 14 days prior to the start of the study.
3. BMI<30 or the volunteer is not considered obese by the Principal Investigator with a written statement at screening.
4. Willing and able to abide by the dietary requirements of the study.
5. Willing and able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee.

Exclusion Criteria:

1. History of known or suspected clinically significant hypersensitivity to any drug.
2. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
3. Clinically significant cardiovascular, hepatic, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, coagulation or neoplastic disorders.
4. Participation in radiologic studies involving parenteral administration of iodinated contrast materials within two weeks prior to screening.
5. Subjects with history of recent alcohol abuse (defined as consumption of more than 21- ml of alcohol per week; or the equivalent of fourteen 4-oz glasses of wine, fourteen 12 oz can/bottle of beer or wine cooler) or other substance abuse.
6. Any protocol-required laboratory test abnormality that is considered clinically significant.
7. Participation in another investigational drug study within 90 days before the first day of dosing.
8. History of non-compliance to medical regimens, or subjects who are considered potentially unreliable.
9. Blood or plasma donation within the past 90 days.
10. Mentally unstable or incompetent.
11. Positive hepatitis C screen or positive hepatitis B screen.
12. HIV positive

B. Type 2 diabetic patients

Inclusion Criteria:

1. Type 2 male patients and post-menopausal females aged 30-70 years.
2. HA1c 6.5-10%
3. Naïve or treated with Metformin only
4. BMI< 35
5. Willing and able to abide by the dietary requirements of the study.
6. Willing and able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee.

Exclusion Criteria:

1. History of known or suspected clinically significant hypersensitivity to any drug.
2. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
3. Clinically significant cardiovascular, hepatic, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, coagulation or neoplastic disorders.
4. Participation in radiologic studies involving parenteral administration of iodinated contrast materials within two weeks prior to screening.
5. Subjects with history of recent alcohol abuse (defined as consumption of more than 21- ml of alcohol per week; or the equivalent of fourteen 4-oz glasses of wine, fourteen 12 oz can/bottle of beer or wine cooler) or other substance abuse.
6. Any protocol-required laboratory test abnormality that is considered clinically significant.
7. Participation in another investigational drug study within 90 days before the first day of dosing.
8. History of non-compliance to medical regimens, or subjects who are considered potentially unreliable.
9. Blood or plasma donation within the past 90 days.
10. Mentally unstable or incompetent.
11. Positive hepatitis C screen or positive hepatitis B screen.
12. HIV positive

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; 10 healthy volunteers will receive 0.1 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order	Device: MicronJet; The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.; Device: MicronJet; MicronJet, Intradermal Injection; Other Names: Microneedles
EXPERIMENTAL: 2; 10 Type II DM subject will receive 0.2 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order	Device: MicronJet; The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.; Device: MicronJet; MicronJet, Intradermal Injection; Other Names: Microneedles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood samples for PK and PD will be collected	pre dose and up to 360 minutes post dose of administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires	All study duration

Collaborators and Investigators

• Sponsor: NanoPass Technologies Ltd
• Investigators: Principal Investigator: Itamar Raz, MD, Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: December 30, 2007
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (ESTIMATE): January 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Intradermal; MicronJet (microneedles)
• Other Study ID Numbers: NP-1-001