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

Phase 2RecruitingNCT07224321

Mannkind Corporation100 enrolled

Overview

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 10 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Type 1 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 10 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 * Investigator believes that participant can be expected to follow the study protocol * No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study Exclusion Criteria: * 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 * Positive urine pregnancy test for female subjects of childbearing potential

Locations (10)

Children's Hospital Los Angeles

Los Angeles, California, United States

NOT_YET_RECRUITING

University of California San Francisco

San Francisco, California, United States

NOT_YET_RECRUITING

Barbara Davis Center for Diabetes Young Adult Clinic

Aurora, Colorado, United States

RECRUITING

Yale University

New Haven, Connecticut, United States

NOT_YET_RECRUITING

University of Florida

Gainesville, Florida, United States

NOT_YET_RECRUITING

Indiana University

Indianapolis, Indiana, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

NOT_YET_RECRUITING

Baylor College of Medicine

Houston, Texas, United States

NOT_YET_RECRUITING

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

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

Mean Continuous Glucose Monitoring (CGM) glucose

Mean CGM glucose from baseline to 13 weeks

Time frame: 13 weeks

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

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

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

Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL

Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL from baseline to 13 weeks

Time frame: 13 weeks

Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL

Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL from baseline to 13 weeks

Time frame: 13 weeks

Continuous Glucose Monitoring (CGM) measured coefficient of variation

CGM-measured coefficient of variation from baseline to 13 weeks

Time frame: 13 weeks

Change in glycated hemoglobin (HbA1c)

Change in HbA1c from baseline to 13 weeks

Time frame: 13 weeks

Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver

Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16; now listed as 1-5) and Delivery System subscale (items 17-22; now listed as 6-11) and one additional item added by study team (#12). Higher scores indicate less treatment satisfaction.

Time frame: 13 weeks

Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant

Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16) and Delivery System subscale (items 17-22). Higher scores indicate less treatment satisfaction.

Time frame: 13 weeks

Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver

Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16; now listed as 1-5) and Delivery System subscale (items 17-22; now listed as 6-11) and one additional item added by study team (#12) Higher scores indicate less treatment satisfaction.

Time frame: 39 weeks

Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant

Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16) and Delivery System subscale (items 17-22) Higher scores indicate less treatment satisfaction.

Time frame: 39 weeks

Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen

Percentage of participants using Afrezza-BI regimen at time of 13-week visit

Time frame: At 13 weeks

Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen

Percentage of participants that continue on Afrezza-BI after 13-week visit

Time frame: After 13 weeks

Incidence of Adverse Events of Special Interest (AESIs)

Incidence and severity of AESIs which include the following events: acute bronchospasm, clinically relevant decline in pulmonary function (\>15% decline from baseline percent predicted FEV1 accompanied by respiratory symptoms), hypersensitivity reactions, including anaphylaxis, hospitalization for asthma, use of corticosteroid bursts for diagnosis of asthma, diagnosis of asthma, diabetic ketoacidosis, severe hypoglycemia

Time frame: 13 weeks

Incidence of Adverse Events of Special Interest (AESIs)

Time frame: 39 weeks

Change in percent predicted FEV1

Change in percent predicted FEV1 from baseline to Week 13

Time frame: 13 weeks

Change in percent predicted FEV1

Change in percent predicted FEV1 from baseline to Week 39

Time frame: 39 weeks

Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Incidence and severity of TEAEs and SAEs

Time frame: 13 weeks

Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Incidence and severity of TEAEs and SAEs

Time frame: 39 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts