Clinical Trial

Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes

Study acronym: INHALE-GDM

Recruiting Phase 2/3

Record status

This record was last updated May 15, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Summary

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.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2024-07-30; most recent amendment 2025-05-13.

Status change: Not Yet Recruiting → Recruiting 2025-05-13

Trial Details

NCT Number	NCT06535789
Lead Sponsor	Jaeb Center for Health Research Collaborators: Mannkind Corporation
Conditions	Diabetes, Gestational, Pregnancy Complications, Glucose Metabolism Disorders, Glucose Intolerance During Pregnancy
Enrollment	30 participants
Start Date	2025-05
Primary Completion	2025-07 (estimated)
Study Completion	2025-07 (estimated)
Updated on ClinicalTrials.gov	2025-05-15