Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Percentage of HbA1c From Baseline to 3 Months
研究概览
简要总结
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
详细描述
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
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
- •Adult type 2 diabetes patients age 18 or older
- •HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination.
- •Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated).
排除标准
- •History of asthma, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
- •Forced Expiratory Volume in one second (FEV1) under 70% predicted
- •Pregnancy
- •Active malignancies and/or life expectancy of < 12 months
- •Major surgery planned during study period
- •Currently using rapid acting insulins - Novolog, Humalog, Apidra
- •Prior use of Afrezza in the last 3 months
- •Unwilling to test blood glucose before or after each meal
- •Exposure to systemic glucocorticoids within 6 weeks of screening
- •Severe hypoglycemia in last 6 months or hypoglycemia unawareness
- •Any medical condition which, in the opinion of the investigator, would interfere with ability to understand or respond to the administration of inhaled insulin
研究组 & 干预措施
Addition of mealtime Afrezza Inhalation Powder
Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm
干预措施: Afrezza Inhalant Product (Drug)
结局指标
主要结局
Change in Percentage of HbA1c From Baseline to 3 Months
时间窗: Baseline to 3 months
Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower
次要结局
- Percentage of Patients With HbA1c Under 7% at 3 Months(3 months)
- Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS(3 months)
研究者
Philip Levin
Senior Director of Clinical Research
Model Clinical Research LLC