PK/PD Study of Intranasal Insulin in Type I Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hompesch, Marcus, M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Profil Institute for Clinical Research, Inc.
Information provided by:
Hompesch, Marcus, M.D.
ClinicalTrials.gov Identifier:
NCT01201278
First received: September 13, 2010
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: Insulin
Drug: Insulin LISPRO
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hompesch, Marcus, M.D.:

Primary Outcome Measures:
  • Insulin tolerability, PK, and PD [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    To assess safety and tolerability, and to compare the insulin AUC over 0-120 min for each of the three insulin applications.


Estimated Enrollment: 20
Arms Assigned Interventions
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
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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01201278

Contacts
Contact: Marcus Hompesch, MD (619) 427-1300 marcus.hompesch@profilinstitute.com

Locations
United States, California
Profil Institute for Clinical Research Not yet recruiting
Chula Vista, California, United States, 91911
Principal Investigator: Marcus Hompesch, MD         
Sponsors and Collaborators
Hompesch, Marcus, M.D.
Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Hompesch, Marcus, M.D., Profil Institute for Clinical Research, Inc.
ClinicalTrials.gov Identifier: NCT01201278     History of Changes
Other Study ID Numbers: NI2010-001
Study First Received: September 13, 2010
Last Updated: June 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Hompesch, Marcus, M.D.:
intranasal insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014