Inhaled Insulin for Gestational Diabetes

(INHALE-GDM Trial)

Recruiting at 7 trial locations

Overseen By Carol Levy, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Jaeb Center for Health Research

Must be taking: Rapid-acting insulin

Must not be taking: Non-insulin glucose-lowering, Glucocorticoids

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Asthma, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different insulin treatments affect blood sugar levels after eating in pregnant women with gestational diabetes. Participants will compare their usual injected insulin with a newer inhaled insulin, Technosphere Insulin, during two separate meal sessions. Researchers aim to determine which method controls blood sugar more effectively. Women between 24 and 34 weeks pregnant with gestational diabetes who already use insulin before meals might be suitable for this study. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in diabetes care.

Do I need to stop my current medications for the trial?

You will need to stop using any non-insulin glucose-lowering medications and cannot use inhaled insulin (Afrezza) or regular insulin. If you are using more than 20 units of rapid-acting insulin at breakfast, you will also need to adjust that.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that technosphere insulin (TI) is a safe option for managing diabetes during pregnancy. One study found that TI serves as a safe alternative to rapid-acting insulin analogs (RAA), which are usually injected. In a 90-day study, TI did not present any new safety issues and effectively controlled blood sugar levels.

Although both TI and RAA can cross the placenta, making them secondary choices according to the American Diabetes Association, they are often used when necessary. Generally, TI has been well-tolerated without major side effects.

Participants in clinical trials using TI have not reported serious side effects. Overall, TI appears to be a promising option for managing blood sugar, especially for those who prefer inhaling insulin instead of receiving injections. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for gestational diabetes, which typically involves injectable rapid-acting insulin analogs, Technosphere Insulin (TI) is administered as an inhalable powder. This unique delivery method offers a more convenient and needle-free option, potentially increasing comfort and adherence for pregnant women managing their blood sugar levels. Researchers are excited because inhaled insulin can act more rapidly, mimicking the body's natural insulin response to meals more closely than traditional injections. This could lead to better blood glucose control and improved outcomes for both mothers and their babies.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

Research has shown that technosphere insulin (TI), which participants in this trial may receive, can help manage blood sugar in people with diabetes, including pregnant women. One study found that TI works well without introducing new safety issues. Another study demonstrated that, outside of pregnancy, TI poses a lower risk of causing low blood sugar compared to rapid-acting insulin analogs (RAA), another treatment option in this trial. Although more research is needed to fully understand TI's effectiveness during pregnancy, early results are promising for controlling blood sugar after meals. Case reports also support TI as a safe method for managing diabetes during pregnancy. ^{1 2 3 4 5}

Who Is on the Research Team?

Amy Valent, DO

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Diagnosis of GDM via standard 1-step or 2-step criteria

I use insulin for breakfast, and my dose is less than 20 units.

Ability to provide informed consent for study participation

Exclusion Criteria

Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening

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

I have diabetes, with high blood sugar levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will undergo two meal sessions where they will use either rapid-acting insulin analog or technosphere insulin to manage their blood glucose

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including glucose levels post-prandial

3-5 hours

What Are the Treatments Tested in This Trial?

Interventions

• Technosphere Insulin

Trial Overview 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.

How Is the Trial Designed?

Group I: technosphere insulin (TI) Experimental Treatment 1 Intervention

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

Group II: Rapid-acting insulin analog Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Mannkind Corporation

Industry Sponsor

Trials

61

Recruited

8,400+

Michael E. Castagna

Mannkind Corporation

Chief Executive Officer since 2017

PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania

Burkhard Blank

Mannkind Corporation

Chief Medical Officer since 2021

MD

Citations

1. contemporaryobgyn.net contemporaryobgyn.net/view/study-finds-technosphere-insulin-safe-for-managing-diabetes-in-pregnancy

Study finds technosphere insulin safe for managing ... Study finds technosphere insulin safe for managing diabetes in pregnancy. A new case series highlights technosphere insulin as an effective ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06535789

Inhaled Insulin vs Rapid-acting Injections for Post-meal ... TI's optimal dosing, efficacy and risk for hypoglycemia in pregnancy is unknown. Outside of pregnancy, TI has been shown to cause less hypoglycemia than RAA ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317946/

Safety and Efficacy of Inhaled Technosphere® Insulin in the ... A post hoc analysis from a 90-day proof-of-concept study demonstrated increased efficacy and no new safety concerns for an ultra-rapid-acting ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pmf2.70065

Inhaled insulin in pregnancy: A case series supporting ... This case series demonstrates the various management approaches of TI use in pregnant patients with preexisting diabetes. Minimal data are ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/3/353/157574/A-Randomized-Trial-Comparing-Inhaled-Insulin-Plus

A Randomized Trial Comparing Inhaled Insulin Plus Basal ... Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group and ...