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Insulin

Inhaled Insulin for Type 1 Diabetes

Phase 1
Waitlist Available
Research Sponsored by Hompesch, Marcus, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 diabetes clinically diagnosed ≥ 12 months.
Male and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will compare the safety and side effects of two doses of inhaled regular insulin to a single dose of the rapid-acting insulin analog lispro.

Who is the study for?
This trial is for men and women aged 18-65 with Type 1 diabetes, diagnosed at least a year ago. Participants should have a BMI of 18-28 kg/m², an HbA1c level of ≤10%, and be on multiple daily insulin injections or an insulin pump for over a year. They must also have low fasting serum C-peptide levels.
What is being tested?
The study compares the safety and effects of two doses of intranasal regular human insulin against one dose of subcutaneous rapid-acting Insulin Lispro (Humalog®). It will use the euglycemic glucose clamp technique to measure how the body responds to these insulins.
What are the potential side effects?
Potential side effects may include discomfort or irritation in the nose from intranasal delivery, typical insulin-related side effects like hypoglycemia (low blood sugar), allergic reactions, injection site reactions, and headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 1 diabetes for over a year.
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I am between 18 and 65 years old and have type 1 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin tolerability, PK, and PD

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nasal insulin 8 IUExperimental Treatment1 Intervention
Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
Group II: Nasal insulin 16 IUExperimental Treatment1 Intervention
Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
Group III: Subcutaneous insulin lispro 8 UActive Control1 Intervention
Subcutaneous insulin lispro (Humalog®) 8 U
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

Hompesch, Marcus, M.D.Lead Sponsor
Profil Institute for Clinical Research, Inc.OTHER
4 Previous Clinical Trials
172 Total Patients Enrolled

Media Library

Intranasal Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT01201278 — Phase 1
Type 1 Diabetes Research Study Groups: Nasal insulin 16 IU, Subcutaneous insulin lispro 8 U, Nasal insulin 8 IU
Type 1 Diabetes Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT01201278 — Phase 1
Intranasal Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01201278 — Phase 1
~13 spots leftby Dec 2025
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