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Insulin

Inhaled Insulin for Diabetes

Phase 1

Waitlist Available

Led By Marcus Hompesch, MD

Research Sponsored by QDose Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male

Non smoking for at least 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial looks at the effects of inhaling different doses of insulin powder, compared to injecting it under the skin, in healthy male volunteers.

Who is the study for?

This trial is for healthy, non-smoking males with a BMI of 28 or less. They must have normal lung function and no significant health issues. Participants cannot have diabetes, drug abuse history, HIV, hepatitis B/C, or be on recent medications including over-the-counter ones.Check my eligibility

What is being tested?

The study tests how different doses of inhaled powdered insulin compare to injected regular insulin in controlling blood sugar under controlled conditions (euglycemic clamp) in healthy men.See study design

What are the potential side effects?

Potential side effects may include coughing or throat irritation from the inhaler device and typical insulin-related side effects such as low blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am male.

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I have not smoked for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

maximum insulin serum concentration

Secondary outcome measures

AUC

Tmax

early T50%

+2 more

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

QDose LimitedLead Sponsor

Marcus Hompesch, MDPrincipal InvestigatorProfil Institute for Clinical Research Incorporated

8 Previous Clinical Trials

243 Total Patients Enrolled

1 Trials studying Diabetes

42 Patients Enrolled for Diabetes

Media Library

Recombinant Human Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT00426920 — Phase 1

Diabetes Clinical Trial 2023: Recombinant Human Insulin Highlights & Side Effects. Trial Name: NCT00426920 — Phase 1

Recombinant Human Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00426920 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research limited to those over a certain age?

"This research project is only open to those aged 18-45. Conversely, there are 185 clinical trials available for minors and 874 studies targeting the elderly population."

Answered by AI

Has this treatment been green-lighted by the Food and Drug Administration?

"Safety of the proposed treatment is only moderately known, so it was assigned a score of 1. This rating has been determined due to its status as an experimental Phase 1 trial and limited evidence supporting efficacy or safety."

Answered by AI

Is the recruitment for this trial ongoing?

"According to clinicaltrials.gov, this trial is not currently recruiting new participants; the posting was initially published on February 1st 2007 and most recently updated on January 24th 2007. Nevertheless, there are 1170 other medical studies actively searching for volunteers at present."

Answered by AI

Could I qualify to become an active participant in this experiment?

"In order to be eligible for this diabetes mellitus research study, potential participants must fall within the 18-45 age range. The investigators are seeking a total of 14 individuals who meet these criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

2007. "Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00426920.

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