PK/PD Study of Intranasal Insulin in Type I Diabetes

NCT01201278 | Unknown Phase 1

• 1 other identifier: NI2010-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

intranasal insulin

Outcome Measures

Primary Outcomes (1)

• Insulin tolerability, PK, and PD

  To assess safety and tolerability, and to compare the insulin AUC over 0-120 min for each of the three insulin applications.

  120 minutes

Study Arms (3)

Nasal insulin 8 IU

EXPERIMENTAL

Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin

Drug: Insulin

Nasal insulin 16 IU

EXPERIMENTAL

Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin

Drug: Insulin

Subcutaneous insulin lispro 8 U

ACTIVE COMPARATOR

Subcutaneous insulin lispro (Humalog®) 8 U

Drug: Insulin LISPRO

Interventions

Insulin DRUG

Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin

Nasal insulin 8 IU

Insulin LISPRO DRUG

Subcutaneous insulin lispro 8 U

Subcutaneous insulin lispro 8 U

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• History of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization.
• Clinically significant abnormal ECG at screening, as judged by the Investigator.
• Clinically significant abnormalities in vital signs at screening, as judged by the Investigator.
• Known allergy to trial product or any other ingredient in the study drug.
• Positive HIV 1 (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
• History or evidence of alcohol or drug abuse within the past 3 years.
• 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.
• 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.
• Blood donation or high volume phlebotomy, e.g., \>500 mL, within 56 days before dosing.
• Participation in a study of any investigational drug or device 30 days before enrollment in this study.
• The subject is unfit for the study in the opinion of the investigator.
• 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).

Sponsors & Collaborators

• Hompesch, Marcus, M.D.: lead
• Profil Institute for Clinical Research, Inc.: collaborator

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Central Study Contacts

Marcus Hompesch, MD

CONTACT

(619) 427-1300; marcus.hompesch@profilinstitute.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Last Updated: June 17, 2011

Record last verified: 2011-06

Locations

US (1)