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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoPass Technologies Ltd
ClinicalTrials.gov Identifier:
NCT00602914
First received: December 30, 2007
Last updated: May 8, 2013
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Intradermal Injections
Device: MicronJet
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NanoPass Technologies Ltd:

Primary Outcome Measures:
  • Blood samples for PK and PD will be collected [ Time Frame: pre dose and up to 360 minutes post dose of administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires [ Time Frame: All study duration ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • MicronJet
  • 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:
  • MicronJet
  • Microneedles

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602914

Sponsors and Collaborators
NanoPass Technologies Ltd
Investigators
Principal Investigator: Itamar Raz, MD Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: NanoPass Technologies Ltd
ClinicalTrials.gov Identifier: NCT00602914     History of Changes
Other Study ID Numbers: NP-1-001
Study First Received: December 30, 2007
Last Updated: May 8, 2013
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by NanoPass Technologies Ltd:
MicronJet (microneedles)
Intradermal

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014