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MannKind CorpINHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes Fase IV 141 Aleatorizado
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El ensayo clínico NCT05904743 tuvo como objetivo estudiar el tratamiento de Diabetes mellitus tipo 1. Este fue un estudio intervencionista de Fase IV. Su estado actual es: completado. El estudio se inició el 7 de julio de 2023, con el objetivo de reclutar a 141 participantes. Dirigido por MannKind Corp, la fecha de finalización prevista fue el 24 de junio de 2024. Los datos se actualizaron por última vez en ClinicalTrials.gov el 9 de agosto de 2024.
Resumen
INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary...Mostrar más
Título oficial
INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Condiciones médicas
Diabetes mellitus tipo 1Otros ID del estudio
- MKC-TI-193
Número del NCT
Inicio del estudio (real)
2023-07-07
Última actualización
2024-08-09
Fecha de finalización (estimada)
2024-06-24
Inscripción (prevista)
141
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Completado
Palabras clave
Diabetes Mellitus
Insulin
Inhaled
Afrezza
Technosphere
Adults
Degludec
Glucose sensors
Insulin pumps
CGM
Insulin
Inhaled
Afrezza
Technosphere
Adults
Degludec
Glucose sensors
Insulin pumps
CGM
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalAfrezza (Technosphere Insulin) + insulin degludec The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase. Dexcom Continuous Glucose Monitoring (CGM) will be provided. The Afrezza-Degludec group will continue to use Afrezza and insulin degludec for an additional 13 weeks in the Extension Phase. | Afrezza Pharmaceutical form: powder Route of administration: inhalation insulin degludec Pharmaceutical form: solution for injection Route of administration: subcutaneous |
Comparador activoUsual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGM The Usual Care group will continue to receive insulin as they did before the study. This could be by multiple daily injections (MDI) or by using an insulin pump with or without automation for the 17 weeks of the randomized controlled trial (RCT) Phase. Participants will continue to use their personal continuous glucose monitor (CGM) as they did before the study. The Usual Care group will then use Afrezza and insulin ...Mostrar más | Rapid-acting Insulin Analog Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous Basal Insulin Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in glycated hemoglobin (HbA1c) | Change in HbA1c from baseline to 17 weeks (non-inferiority margin 0.4%) | 17 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Continuous Glucose Monitoring (CGM) measured percent time with glucose less than 54 mg/dL | CGM-measured percent time with glucose \<54 mg/dL from baseline to 17 weeks (non-inferiority, margin 0.5%) | 17 weeks |
Continuous Glucose Monitoring (CGM) measured percent time with glucose less than 70 mg/dL | CGM-measured percent time with glucose \<70mg/dL from baseline to 17 weeks (non-inferiority, margin 2.0%) | 17 weeks |
Continuous Glucose Monitoring (CGM) measured daytime (0600-midnight) percent time in range with glucose 70-180 mg/dL | CGM-measured daytime (0600-midnight) percent time in range with glucose 70-180 mg/dL from baseline to 17 weeks, for superiority assessment | 17 weeks |
Mean Continuous Glucose Monitoring (CGM) glucose | Mean CGM glucose from baseline to 17 weeks, for superiority assessment | 17 weeks |
Continuous Glucose Monitoring (CGM) measured (24-hours) percent time in range (TIR) with glucose 70-180 mg/dL | CGM-measured (24-hours) percent time in range with glucose 70-180 mg/dL from baseline to 17 weeks, for superiority assessment | 17 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 17 weeks, for superiority assessment | 17 weeks |
Change in glycated hemoglobin (HbA1c) for superiority assessment | HbA1c from baseline to 17 weeks, for superiority assessment | 17 weeks |
Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL | CGM-measured time with glucose \>250 mg/dL from baseline to 17 weeks, for superiority assessment | 17 weeks |
Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL | CGM-measured time with glucose \<70 mg/dL from baseline to 17 weeks, for superiority assessment | 17 weeks |
Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL | CGM-measured time with glucose \<54 mg/dL from baseline to 17 weeks, for superiority assessment | 17 weeks |
Continuous Glucose Monitoring (CGM) measured coefficient of variation | CGM-measured coefficient of variation from baseline to 17 weeks, for superiority assessment | 17 weeks |
Change in HbA1c less than 7.0% at 17 weeks | HbA1c \<7.0% at 17 weeks | 17 weeks |
Change in HbA1c from baseline to 17 weeks, with an improvement of greater than 0.5% | HbA1c improvement from baseline to 17 weeks \>0.5% | 17 weeks |
Change in HbA1c from baseline to 17 weeks, with an improvement of greater than 1.0% | HbA1c improvement from baseline to 17 weeks \>1.0% | 17 weeks |
Percent time in range (TIR) with glucose 70-140 mg/dL | Percent time in range with glucose 70-140 mg/dL | 17 weeks |
Percent time with glucose greater than 300 mg/dL | Percent time with glucose \>300 mg/dL | 17 weeks |
Continuous Glucose Monitoring (CGM) measured prolonged hyperglycemia events | CGM-measured prolonged hyperglycemia events | 17 weeks |
Continuous Glucose Monitoring (CGM) measured hypoglycemia events | CGM-measured hypoglycemia events | 17 weeks |
Standard Deviation (SD) of glucose | SD of glucose | 17 weeks |
"Fasting glucose" by Continuous Glucose Monitoring (CGM) | "Fasting glucose" by CGM (defined as closest value to 6 a.m.; assumed, but not verified, with no food during the prior 4-hour period) | 17 weeks |
Percent time in range (TIR) with glucose 70-180 mg/dL greater than 70% | Percent time in range with glucose 70-180 mg/dL \>70% at 17 weeks | 17 weeks |
Percent time in range (TIR) with glucose 70-180 mg/dL improvement from baseline to 17 weeks greater than or equal to 5% | Percent time in range with glucose 70-180 mg/dL improvement from baseline to 17 weeks ≥5% | 17 weeks |
Percent time in range (TIR) with glucose 70-180 mg/dL improvement from baseline to 17 weeks ≥10% | Percent time in range with glucose 70-180 mg/dL improvement from baseline to 17 weeks ≥10% | 17 weeks |
Percent time with glucose less than 70 mg/dL less than 4% | Percent time with glucose \<70 mg/dL \<4% at 17 weeks | 17 weeks |
Percent time with glucose less than 54 mg/dL less than1% | Percent time with glucose \<54 mg/dL \<1% at 17 weeks | 17 weeks |
Percent time in range (TIR) 70-180 mg/dL greater than 70% and time less than 54 mg/dL less than 1% | Percent time in range 70-180 mg/dL \>70% and time \<54 mg/dL \<1% at 17 weeks | 17 weeks |
Incidence of severe hypoglycemia events | Incidence of severe hypoclycemia events, defined as events requiring assistance of another person due to cognitive impairment to actively administer carbohydrate, glucagon, or other resuscitative actions | 30 weeks |
Continuous Glucose Monitoring (CGM) measured percent time with glucose less than 54 mg/dL | CGM-measured percent time with glucose less than 54 mg/dL | 30 weeks |
Other serious adverse events, including hospitalizations | Other serious adverse events, including hospitalizations | 30 weeks |
Incidence and severity of treatment-emergent adverse events (TEAEs) | Incidence and severity of treatment-emergent adverse events (TEAEs) | 30 weeks |
Incidence and severity of adverse events of special interest (AESIs) as well as the number of participants with AESIs and number of individual events | Incidence and severity of adverse events of special interest (AESIs) as well as the number of participants with AESIs and number of individual events | 30 weeks |
Change from baseline to 17 weeks in Forced Expiratory Volume in one second (FEV1) | Change from baseline to 17 weeks in FEV1 | 17 weeks |
Proportion of participants with Forced Expiratory Volume in one second (FEV1) reduction greater than or equal to 20% | Proportions of participants in each group who have experienced ≥20% reduction in FEV1 from baseline to Week 17 | 30 weeks |
Hypoglycemic events from logged blood glucose measurements (BGM): Level 1 events (less than 70 mg/dL) and Level 2 events (less than 54 mg/dL) separately | Hypoglycemic events from logged BGM measurements: Level 1 events (\<70 mg/dL) and Level 2 events (\<54 mg/dL) | 30 weeks |
Hyperglycemic events from logged blood glucose measurements (BGM) | Hyperglycemic events from logged BGM measurements | 30 weeks |
Continuous Glucose Monitoring (CGM) measured prolonged hyperglycemia events | CGM-measured prolonged hyperglycemia events | 30 weeks |
Continuous Glucose Monitoring (CGM) measured hypoglycemia events (both a safety and efficacy endpoint) | CGM-measured hypoglycemia events (both a safety and efficacy endpoint) | 30 weeks |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Ability to provide informed consent for study participation
Clinical diagnosis of T1D (per the Investigator)
Treatment with insulin for at least 6 months prior to the collection of the baseline continuous glucose monitoring (CGM) data
Same treatment regimen (MDI, an AID system, or an insulin pump without automation) for the 3 months prior to screening
- Current (at time of screening) rapid-acting insulin analog (RAA) in use for at least 4 weeks
- If AID system used, automated insulin delivery must be active >85% of the time in the 4 weeks prior to screening
- If MDI used, participant must be using a long-acting basal insulin plus injecting a RAA bolus for meals, per Investigator
Total daily insulin dose 20-100 units
Age ≥ 18 years
HbA1c <11.0%
Participant uses real-time CGM (any type of real-time CGM) on a regular basis (at least 70% of the time in the 4 weeks prior to screening)
No use of inhaled insulin in the 3 months prior to screening
If female of childbearing potential, willing and able to have pregnancy testing
Investigator believes that the participant can safely use the study treatment and will follow protocol
No medical, psychiatric,or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study
- This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.
- History of recent blood transfusions (within previous 3 months prior to randomization), hemoglobinopathies, (sickle cell trait is not an exclusion), or any other conditions that affect HbA1c measurements
- Recent history of asthma (defined as using any medications to treat within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator
- Exposure to any investigational product(s), including drugs or devices, in the 90 days prior to the start of screening
- Any disease other than diabetes or current use (or anticipated use during the study) of any medication that, in the judgment of the Investigator, may impact glucose metabolism
- Current or anticipated acute uses of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)
- Use of a non-insulin glucose-lowering medication within 3 months prior to signing informed consent
- Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening
- Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on an acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal
- No known stage 4/5 renal failure or on dialysis
- Taking Hydroxyurea medication
- An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
- An episode of diabetic ketoacidosis (DKA) diagnosed at a health care facility within the 90 days prior to screening or severe hypoglycemia event within the 90 days prior to screening
- Employed by, or having immediate family members employed by MannKind Corporation or JAEB Center for Health Research, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as Study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in in conducting the clinical trial
- Have a history or current diagnosis of lung cancer
MannKind Corp5 estudios activos para explorarJaeb Center for Health ResearchNo hay datos de contacto.
19 Centros del estudio en 1 países
California
Loma Linda University-Diabetes Treatment Center, Loma Linda, California, 92354, United States
Sansum Diabetes Research, Santa Barbara, California, 93105, United States
Colorado
Barbara Davis Center, Aurora, Colorado, 80045, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Illinois
Northwestern University Division of Endocrinology, Metabolism and Molecular Medicine, Chicago, Illinois, 60611, United States
Iowa
Iowa Diabetes Research, West Des Moines, Iowa, 50265, United States
Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
Nevada
Las Vegas Endocrinology, Henderson, Nevada, 89074, United States
New York
Endocrine Associate of West Village, PC, Long Island City, New York, 11106, United States
Mount Sinai Diabetes Center, New York, New York, 10075, United States
SUNY Upstate Medical University, Syracuse, New York, 13210, United States
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Texas
Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
Diabetes and Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
Washington
University of Washington Diabetes Institute, Seattle, Washington, 98119, United States
West Virginia
Mountain State Diabetes, Parkersburg, West Virginia, 26101, United States