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临床试验/NCT05904743
NCT05904743已完成4 期

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

Mannkind Corporation37 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2023年7月7日最近更新:
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适应症

试验速览

阶段
4 期
状态
已完成
入组人数
141
试验地点
37
主要终点
Change in glycated hemoglobin (HbA1c)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

结局指标

主要结局

Change in glycated hemoglobin (HbA1c)

时间窗: 17 weeks

Change in HbA1c from baseline to 17 weeks (non-inferiority margin 0.4%)

次要结局

  • Continuous Glucose Monitoring (CGM) measured percent time with glucose less than 70 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured daytime (0600-midnight) percent time in range with glucose 70-180 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured coefficient of variation(17 weeks)
  • Percent time in range (TIR) with glucose 70-140 mg/dL(17 weeks)
  • Percent time with glucose greater than 300 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured prolonged hyperglycemia events(30 weeks)
  • Standard Deviation (SD) of glucose(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured percent time with glucose less than 54 mg/dL(30 weeks)
  • Change in glycated hemoglobin (HbA1c) for superiority assessment(17 weeks)
  • Change in HbA1c less than 7.0% at 17 weeks(17 weeks)
  • Change in HbA1c from baseline to 17 weeks, with an improvement of greater than 0.5%(17 weeks)
  • Change in HbA1c from baseline to 17 weeks, with an improvement of greater than 1.0%(17 weeks)
  • Mean Continuous Glucose Monitoring (CGM) glucose(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured (24-hours) percent time in range (TIR) with glucose 70-180 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured hypoglycemia events(17 weeks)
  • Percent time with glucose less than 54 mg/dL less than1%(17 weeks)
  • "Fasting glucose" by Continuous Glucose Monitoring (CGM)(17 weeks)
  • Percent time in range (TIR) with glucose 70-180 mg/dL greater than 70%(17 weeks)
  • Percent time in range (TIR) with glucose 70-180 mg/dL improvement from baseline to 17 weeks ≥10%(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%(17 weeks)
  • Percent time with glucose less than 70 mg/dL less than 4%(17 weeks)
  • Percent time in range (TIR) 70-180 mg/dL greater than 70% and time less than 54 mg/dL less than 1%(17 weeks)
  • Incidence of severe hypoglycemia events(30 weeks)
  • Other serious adverse events, including hospitalizations(30 weeks)
  • Incidence and severity of treatment-emergent adverse events (TEAEs)(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(30 weeks)
  • Change from baseline to 17 weeks in Forced Expiratory Volume in one second (FEV1)(17 weeks)
  • Continuous Glucose Monitoring (CGM) measured hypoglycemia events (both a safety and efficacy endpoint)(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(30 weeks)
  • Hyperglycemic events from logged blood glucose measurements (BGM)(30 weeks)
  • Proportion of participants with Forced Expiratory Volume in one second (FEV1) reduction greater than or equal to 20%(30 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (37)

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