INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Afrezza (Technosphere Insulin) + Basal Insulin
Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.
干预措施: Technosphere Insulin (Drug)
Afrezza (Technosphere Insulin) + Basal Insulin
Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.
干预措施: Basal insulin (Drug)
结局指标
主要结局
Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%
时间窗: 13 weeks
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit
次要结局
- Change in percent predicted FEV1(39 weeks)
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(39 weeks)
- Mean Continuous Glucose Monitoring (CGM) glucose(13 weeks)
- Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL(13 weeks)
- Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL(13 weeks)
- Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL(13 weeks)
- Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL(13 weeks)
- Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL(13 weeks)
- Continuous Glucose Monitoring (CGM) measured coefficient of variation(13 weeks)
- Change in glycated hemoglobin (HbA1c)(13 weeks)
- Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen(At 13 weeks)
- Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen(After 13 weeks)
- Incidence of Adverse Events of Special Interest (AESIs)(39 weeks)
- Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver(13 weeks)
- Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant(13 weeks)
- Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver(39 weeks)
- Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant(39 weeks)
- Incidence of Adverse Events of Special Interest (AESIs)(13 weeks)
- Change in percent predicted FEV1(13 weeks)
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(13 weeks)