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

Study acronym: INHALE-GDM
StatusRecruiting
PhasePhase 2/3
Started
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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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Mar 2025 to May 2025
    • Primary and study completion dates: May 2025 to Jul 2025
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 13 to 16
    • Study sites revised (5)
  2. Start date: Sep 2024 to Mar 2025
    • Primary and study completion dates: Dec 2024 to May 2025
    • Site contacts updated at 4 of 5 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06535789
Lead Sponsor Jaeb Center for Health Research
Collaborators: Mannkind Corporation
Conditions
(from sponsor)		 Diabetes, Gestational, Pregnancy Complications, Glucose Metabolism Disorders, Glucose Intolerance During Pregnancy
Related terms Diabetes, Gestational, Glucose Metabolism Disorders, Pregnancy Complications
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov