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Insulin

technosphere insulin (TI) for Pregnancy Complications (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
1. Ability to provide informed consent for study participation
2. Age ≥18 years and \<50 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 hours pp
Awards & highlights

Summary

Pregnant women aged 18-49 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.

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

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
8,354 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
157 Previous Clinical Trials
35,575 Total Patients Enrolled
~20 spots leftby Dec 2024
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