Health TrialsbyHealthPanel

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorMannkind Corporation

About this trial

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 6 to \<18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 6 to <18 years of age

Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria

Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)

Forced Expiratory Volume in One Second (FEV1) >80.0% of predicted Global Lung Function Initiative (GLI) value

Disqualifiers

Prior insulin treatment for stage 2 T1D

In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)

Allergy or known hypersensitivity to human regular insulin

Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking

Trial design

Design model

Single group

Treatments tested in this trial

  • Technosphere Insulin

    Drug

    2 unit

  • Technosphere Insulin

    Drug

    4, 8, 12 units

  • Basal insulin

    Drug

    subcutaneously-injected basal insulin

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Afrezza (Technosphere Insulin) + Basal InsulinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%

Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit

Time frame
13 weeks

Secondary outcomes

1

Mean Continuous Glucose Monitoring (CGM) glucose

Mean CGM glucose from baseline to 13 weeks

Time frame
13 weeks
2

Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL

Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL from baseline to 13 weeks

Time frame
13 weeks
3

Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL

CGM-measured percent time with glucose \> 180 mg/dL from baseline to 13 weeks

Time frame
13 weeks
4

Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL

Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL from baseline to 13 weeks

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mannkind Corporation

Lead sponsor

Jaeb Center for Health Research

Collaborator

Source ClinicalTrials.gov
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