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PK/PD Study of Intranasal Insulin in Type I Diabetes

NCT01201278 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-06-17

No results posted yet for this study

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

Interventions

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

DRUG

Insulin LISPRO

Subcutaneous insulin lispro 8 U

Sponsors & Collaborators

  • Profil Institute for Clinical Research, Inc.

    collaborator OTHER

  • Hompesch, Marcus, M.D.

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201278 on ClinicalTrials.gov