Inhaled Insulin for Gestational Diabetes

(INHALE-GDM Trial)

Recruiting at 7 trial locations

Overseen By Jennifer Gurley

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Jaeb Center for Health Research

Must be taking: Rapid-acting insulin

Must not be taking: Non-insulin glucose-lowering, Glucocorticoids

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Asthma, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.

Research Team

Amy Valent, DO

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for pregnant women aged 18-49 with gestational diabetes. Participants should be currently managing their condition with rapid-acting insulin injections. They must attend two meal sessions at the clinic and are willing to try both inhaled and injected insulin.

Inclusion Criteria

Diagnosis of GDM via standard 1-step or 2-step criteria

I use insulin for breakfast, and my dose is less than 20 units.

Ability to provide informed consent for study participation

Exclusion Criteria

Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening

Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

I have diabetes, with high blood sugar levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will undergo two meal sessions where they will use either rapid-acting insulin analog or technosphere insulin to manage their blood glucose

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including glucose levels post-prandial

3-5 hours

Treatment Details

Interventions

• Technosphere Insulin

Trial Overview The study compares the effects of traditional rapid-acting insulin injections versus a new inhaled insulin on blood sugar levels after meals in women with gestational diabetes. Each participant will experience both methods, one per meal session, to see which controls glucose better.

Participant Groups

Group I: technosphere insulin (TI) Experimental Treatment 1 Intervention

All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose

Group II: Rapid-acting insulin analog Active Control 1 Intervention

All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Mannkind Corporation

Industry Sponsor

Trials

61

Recruited

8,400+

Michael E. Castagna

Mannkind Corporation

Chief Executive Officer since 2017

PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania

Burkhard Blank

Mannkind Corporation

Chief Medical Officer since 2021

MD