A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Time In Range
研究概览
简要总结
The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
- •Screening A1c 7.5 % - 11.5% inclusive
- •Willing and able to wear CGM system during the study
- •Willing to use only inhaled insulin (Afrezza®) at meals and for correction
- •Able to understand, speak, read and write English
- •Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy
排除标准
- •Diagnosed with COPD
- •Is an active smoker , or has smoked in the past 6 months
- •Diagnosed with asthma
- •Pregnancy, breast-feeding or planning to become pregnant during study period
- •Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
- •Use of oral or injected corticosteroid within 6 weeks of study enrollment
- •Enrollment in another investigational trial at the time of screening
研究组 & 干预措施
Type 2 Diabetics
Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments.
Participants will wear CMG throughout the study.
At final study visit, CGM system will be collected. A1c, FEV1 and Quality of Life Questionnaires will be collected. Pregnancy test will be collected for all females of child-bearing potential. Participants will be transitioned back to Multiple Daily Injections plus basal or may choose to continue on commercial Afrezza® inhaled insulin plus basal
干预措施: Afrezza Inhalant Product (Drug)
结局指标
主要结局
Time In Range
时间窗: Week 2 to End of Study
Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
Hypoglycemia
时间窗: Week 2 to Week 16
Incidence of significant hypoglycemic events
次要结局
- Hemoglobin A1c(Week 2 to Week 16)
- Quality of Life Questionnaires(Screening to Week 16)