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

NCT06535789 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Diabetes, Gestational
  • Pregnancy Complications
  • Glucose Metabolism Disorders
  • Glucose Intolerance During Pregnancy

Interventions

DRUG

Inhaled Technosphere Insulin

Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal

Sponsors & Collaborators

  • Mannkind Corporation

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Amy Valent, DO · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535789 on ClinicalTrials.gov