← Back to Search

Insulin

Inhaled Insulin for Gestational Diabetes (INHALE-GDM Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose <20 units
Age ≥18 years and <50 years old
Must not have
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)
History or current diagnosis of lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 hours pp
Awards & highlights

Summary

"This trial will study pregnant women with gestational diabetes to see how two different insulin treatments affect their blood sugar after meals. The women will come to the clinic for two meal sessions where they will use either

Who is the study for?
This trial is for pregnant women aged 18-49 with gestational diabetes. Participants should be currently managing their condition with rapid-acting insulin injections. They must attend two meal sessions at the clinic and are willing to try both inhaled and injected insulin.
What is being tested?
The study compares the effects of traditional rapid-acting insulin injections versus a new inhaled insulin on blood sugar levels after meals in women with gestational diabetes. Each participant will experience both methods, one per meal session, to see which controls glucose better.
What are the potential side effects?
Inhaled insulin may cause coughing, throat irritation or pain, headache, nausea, and hypoglycemia (low blood sugar). Rapid-acting injected insulin can also lead to hypoglycemia as well as possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use insulin for breakfast, and my dose is less than 20 units.
Select...
I am between 18 and 49 years old.
Select...
I am pregnant with one baby, between 24-34 weeks along.
Select...
My BMI was between 25-45 before I got pregnant or during my first trimester.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have diabetes, with high blood sugar levels.
Select...
I have or had lung cancer.
Select...
I have diabetes.
Select...
I am currently taking medication to lower my blood sugar that is not insulin.
Select...
I use Afrezza, regular insulin, or more than 20 units of rapid-acting insulin at breakfast.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 hours pp
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 hours pp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-prandial AUC120
Secondary study objectives
AUC >120 mg/dL
AUC >140 mg/dL
Excursion from baseline glucose to peak glucose
+10 more
Other study objectives
Any blood glucose <54 mg/dL
Any blood glucose <63 mg/dL
Any blood glucose <70 mg/dL
+2 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: technosphere insulin (TI)Experimental Treatment1 Intervention
All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose
Group II: Rapid-acting insulin analogActive Control1 Intervention
All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose

Find a Location

Who is running the clinical trial?

Mannkind CorporationIndustry Sponsor
59 Previous Clinical Trials
8,346 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
157 Previous Clinical Trials
35,575 Total Patients Enrolled
~20 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top