ABC [Afrezza With Basal Combination]: A Phase 4 Study of Mealtime Control With Afrezza in Adult Subjects With Type 1 Diabetes Mellitus in Combination With an Automated Insulin Pump or Insulin Degludec
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
A phase 4 study evaluating the efficacy of mealtime control with Afrezza in combination with an automated insulin pump or insulin degludec in adult subjects with type 1 diabetes
详细描述
MKC-TI-192 is a Phase 4, 90-day, randomized, three-arm, multicenter clinical trial evaluating the treatment paradigm and efficacy of Afrezza in controlling postprandial glucose in adult subjects (≥18 years of age) with Type 1 Diabetes Mellitus (T1DM). Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group):
- Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage.
- Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
- AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group).
The study is composed of up to 5 clinic visits (screening, 3 treatment visits, and an end-of-treatment visit) and 9 telephone visits.
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
- •Subjects ≥18 years of age at the time of signing the informed consent form
- •Clinical diagnosis of Type 1 Diabetes
- •HbA1c ≥7.0% and <11.0%
- •Treatment with a CSII pump with an AID algorithm (Medtronic 670G/770G or Tandem Control IQ) for at least 3 months
- •Ability to pay for their own RAA used in the insulin pump or injections, either through co-pay or self-pay, for the duration of the study
- •Willingness to follow study procedures including discontinuing their insulin pump and transitioning to insulin degludec injections plus Afrezza
排除标准
- •A 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, bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
- •History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy)
- •History of hypersensitivity to insulin or any of the Afrezza excipients
- •On dialysis
- •Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
- •Exposure to any investigational drug in the past 30 days or an investigational device in the past 2 weeks
- •Adrenal insufficiency, active use of steroids or planned steroid use
- •Hypothyroidism not controlled, as defined by thyroid stimulating hormone (TSH) outside the upper limit of the reference range by >1.5 × in the last 6 months, according to the local laboratory reference range
- •Hyperthyroidism not controlled, as defined by TSH below the normal reference range, according to the local laboratory
- •Use of antiadrenergic drugs (e.g., beta blockers and clonidine)
- •Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
- •History of a significant eating disorder (e.g., anorexia or bulimia nervosa)
- •Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
- •History of smoking (includes cigarettes, cigars, pipes, vaping devices, and marijuana) in the 6 months before screening
- •Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential and not using adequate contraceptive methods as required by local regulation or practice (may include sexual abstinence)
- •An event of severe hypoglycemia, as reported by the patient, within the last 180 days before screening
- •An episode of diabetic ketoacidosis (DKA), as determined by the Investigator, requiring hospitalization within the last 180 days before screening
- •Exposure to Afrezza in the 30 days before screening
- •Abnormal TSH or creatinine levels above 2.0 mg/dL
研究组 & 干预措施
Afrezza + Automatic Insulin Delivery
Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a CSII pump with an AID algorithm using RAA for their basal and correction insulin coverage.
干预措施: Afrezza (insulin human) Inhalation Powder (Biological)
Afrezza + Automatic Insulin Delivery
Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a CSII pump with an AID algorithm using RAA for their basal and correction insulin coverage.
干预措施: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (Device)
Afrezza + Insulin Degludec
Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
干预措施: Afrezza (insulin human) Inhalation Powder (Biological)
Afrezza + Insulin Degludec
Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
干预措施: insulin degludec (Biological)
AID Control
Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group).
干预措施: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (Device)
结局指标
主要结局
Change in HbA1c
时间窗: 90 days
Change in glycated hemoglobin (HbA1c) from baseline to end of study
次要结局
- Change in Percentage of Time With Glucose <54 mg/dL(baseline and 90 days)
- Events of Level 1 Hypoglycemia (SMBG < 70mg/dL)(90 days)
- Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL)(90 days)
- Events of Severe Hypoglycemia(90 days)
- Change in Time in Range (Glucose of 70 - 180 mg/dL)(baseline and 90 days)
- Change in Time Below Range (Glucose <70 mg/dL)(baseline and 90 days)
- Change in Time Above Range (Glucose >180 mg/dL)(baseline and 90 days)
- Change in Percentage of Time With Glucose >250 mg/dL(baseline and 90 days)
- Change in Coefficient of Variation (CV)(baseline and 90 days)