The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes (INHALE-GDM)

NCT06535789 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	Jaeb Center for Health Research
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	30
Start date	2025-05
Completion	2025-07

Conditions

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

Interventions

• Inhaled Technosphere Insulin

Primary outcomes

• Post-prandial AUC120 — 3 hours from start of meal
  3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)

Countries

United States