PK/PD Study of Intranasal Insulin in Type I Diabetes

June 15, 2011 updated by: Hompesch, Marcus, M.D.

A Phase 1, Randomized, 3-Way Crossover, Investigator Initiated Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Two Doses of Intranasally Administered Regular Human Insulin Compared to a Single Dose of a Subcutaneously Injected Rapid Acting Insulin Analog (Humalog®) in Subjects With Type I Diabetes

This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive.
  2. Type 1 diabetes clinically diagnosed ≥ 12 months.
  3. Treated with multiple daily insulin injections ≥ 12 months or an insulin pump.
  4. HbA1c ≤ 10 % by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
  5. Fasting serum C-peptide ≤ 0.3 nmol/L.
  6. BMI between 18-28 kg/m², inclusive.
  7. Signed, written IRB-approved informed consent.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the PI.
  2. History of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization.
  3. As judged by the investigator, clinically significant findings in laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
  4. Clinically significant abnormal ECG at screening, as judged by the Investigator.
  5. Clinically significant abnormalities in vital signs at screening, as judged by the Investigator.
  6. Known allergy to trial product or any other ingredient in the study drug.
  7. Positive HIV 1 (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
  8. History or evidence of alcohol or drug abuse within the past 3 years.
  9. History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the Investigator.
  10. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.
  11. Blood donation or high volume phlebotomy, e.g., >500 mL, within 56 days before dosing.
  12. Participation in a study of any investigational drug or device 30 days before enrollment in this study.
  13. The subject is unfit for the study in the opinion of the investigator.
  14. Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Nasal insulin 8 IU
Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
Drug: Insulin
Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
Drug: Insulin
Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
EXPERIMENTAL: Nasal insulin 16 IU
Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
Drug: Insulin
Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
Drug: Insulin
Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
ACTIVE_COMPARATOR: Subcutaneous insulin lispro 8 U
Subcutaneous insulin lispro (Humalog®) 8 U
Drug: Insulin LISPRO
Subcutaneous insulin lispro 8 U

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insulin tolerability, PK, and PD
Time Frame: 120 minutes
To assess safety and tolerability, and to compare the insulin AUC over 0-120 min for each of the three insulin applications.
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hompesch, Marcus, M.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Profil Institute for Clinical Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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