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Clinical Trial Details

Trial ID: L2895
Source ID: NCT06535789
Associated Drug: Inhaled Technosphere Insulin
Title: Inhaled Insulin Vs Rapid-acting Injections for Post-meal Glucose Control in Women with Gestational Diabetes
Acronym: INHALE-GDM
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes, Gestational|Pregnancy Complications|Glucose Metabolism Disorders|Glucose Intolerance During Pregnancy
Interventions: DRUG: Inhaled Technosphere Insulin
Outcome Measures: Primary: Post-prandial AUC120, 2-hour post-prandial (PP) area under the curve ≥120 mg/dL (AUC120), 2 hours post-prandial (PP) | Secondary: AUC >120 mg/dL, AUC \>120 mg/dL over 3 hours PP, 3 hours PP|AUC >140 mg/dL, AUC \>140 mg/dL over 3 hours PP, 3 hours PP|Excursion from baseline glucose to peak glucose, Excursion from baseline glucose to peak glucose during 2 hours PP, 2 hours PP|Maximum peak glucose, Maximum peak glucose during 2 hours PP, 2 hours PP|Time to peak glucose, Time to peak glucose during 2 hours PP, 2 hours PP|Time to nadir glucose, Time to nadir (lowest) glucose during 2 hours PP, 2 hours PP|Mean CGM glucose, Mean CGM glucose during 2 hours PP, 2 hours PP|Time with glucose >120 mg/dL, Time with glucose \>120 mg/dL during 3 hours PP, 3 hours PP|Time with glucose >140 mg/dL, Time with glucose \>140 mg/dL during 3 hours PP, 3 hours PP|Glucose ≤140 mg/dL, Glucose ≤140 mg/dL at 1 hour PP, 1 hours PP|Glucose ≤120 mg/dL, Glucose ≤120 mg/dL at 1 hour PP, 1 hours PP|Glucose in range 70-140 mg/dL, Glucose in range 70-140 mg/dL at 1 hour PP, 1 hours PP|Glucose in range 70-120 mg/dL, Glucose in range 70-120 mg/dL at 2 hour PP, 2 hours PP | Other: Any blood glucose <54 mg/dL, Any blood glucose \<54 mg/dL during 3 hours PP, 3 hours PP|Any blood glucose <63 mg/dL, Any blood glucose \<63 mg/dL during 3 hours PP, 3 hours PP|Any blood glucose <70 mg/dL, Any blood glucose \<70 mg/dL during 3 hours PP, 3 hours PP|Percent time glucose <63 mg/dL, CGM-measured percent time with glucose \<63 mg/dL during 3 hours PP, 3 hours PP|Hypersensitivity to inhaled technosphere insulin, Hypersensitivity reaction, acute bronchospasm, treatment provided for asthma symptoms, or other symptoms associated with TI dosing, Up to 5 hours PP
Sponsor/Collaborators: Sponsor: Jaeb Center for Health Research | Collaborators: Mannkind Corporation
Gender: FEMALE
Age: ADULT
Phases: PHASE2|PHASE3
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2025-05
Results First Posted:
Last Update Posted: 2025-03-11
Locations: Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States|University of Colorado School of Medicine, Aurora, Colorado, 80045, United States|Icahn School of Medicine at Mount Sinai, New York City, New York, 10029, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
URL: https://clinicaltrials.gov/show/NCT06535789

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress