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

NCT06535789 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INHALE-GDM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Gestational Diabetes; Inhaled Insulin

Outcome Measures

Primary Outcomes (1)

• Post-prandial AUC120

  3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)

  3 hours from start of meal

Secondary Outcomes (16)

• AUC >140 mg/dL

  3 hours from start of meal

• Excursion from baseline glucose to peak glucose

  3 hours from start of meal

• Maximum peak glucose

  3 hours from start of meal

• Time to peak glucose

  3 hours from start of meal

• Nadir glucose

  3 hours from start of meal

Other Outcomes (7)

• Any blood glucose <54 mg/dL

  3 hours from start of meal

• Any blood glucose <63 mg/dL

  3 hours from start of meal

• Any blood glucose <70 mg/dL

  3 hours from start of meal

Study Arms (2)

technosphere insulin (TI)

EXPERIMENTAL

All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose

Drug: Inhaled Technosphere Insulin

Rapid-acting insulin analog

NO INTERVENTION

All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose

Interventions

Inhaled Technosphere Insulin DRUG

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

technosphere insulin (TI)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide informed consent for study participation
• Age ≥18 years and \<41 years old
• Singleton pregnancy at 24-34 weeks gestation
• Diagnosis of GDM via standard 1-step or 2-step criteria
• Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units
• Pre-pregnancy or first trimester body mass index (BMI) 25-45
• Investigator believes that the protocol can be safely conducted by the participant
• Able to read and speak English

You may not qualify if:

• Type 1 diabetes or type 2 diabetes
• HbA1c ≥ 6.5%, FBG ≥125 mg/dl or 2-hr glucose ≥200 mg/dL on 75g OGTT, or random plasma glucose ≥200 mg/dL (consistent with pre-existing diabetes and not GDM diagnosis)
• Current use of any non-insulin glucose lowering medication
• Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)
• Peak expiratory flow \<80% predicted as measured by peak flow meter
• Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator
• Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening
• History or current diagnosis of lung cancer
• Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)
• Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant
• Recurrent Level 2 (blood glucose \<54 mg/dL) or Level 3 severe hypoglycemia events
• Current use of non-cardio-selective beta blockers
• Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Mannkind Corporation: collaborator

Study Sites (5)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amy Valent, DO

  Oregon Health and Science University

  STUDY CHAIR

Central Study Contacts

Katrina Ruedy, MSPH

CONTACT

813-975-8690; kruedy@jaeb.org

Jennifer Gurley

CONTACT

jgurley@jaeb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete two in-clinic meal sessions, with random assignment to receive either technosphere insulin (TI) or RAA insulin for the first meal and the other insulin for the second meal.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)