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Clinical Trial NCT05243628 (ABC) for Type 1 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Mannkind CorporationAfrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes Phase 4 33
Clinical Trial NCT05243628 (ABC) was designed to study Treatment for Type 1 Diabetes. This was a Phase 4 interventional study that is now completed. The study started on March 31, 2022, with plans to enroll 33 participants. Led by Mannkind Corporation, the expected completion date was October 17, 2022. The latest data from ClinicalTrials.gov was last updated on April 8, 2025.
Brief Summary
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
Detailed Description
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 t...
Official Title
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
Conditions
Type 1 DiabetesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- ABC
- MKC-TI-192
NCT ID Number
Start Date (Actual)
2022-03-31
Last Update Posted
2025-04-08
Completion Date (Estimated)
2022-10-17
Enrollment (Estimated)
33
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Diabetes Mellitus
Insulin
Inhaled Insulin
Afrezza
Technosphere Insulin
Insulin
Inhaled Insulin
Afrezza
Technosphere Insulin
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAfrezza + 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. | Afrezza (insulin human) Inhalation Powder Pharmaceutical form: powder
Route of administration: inhalation Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ |
ExperimentalAfrezza + Insulin Degludec Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. | Afrezza (insulin human) Inhalation Powder Pharmaceutical form: powder
Route of administration: inhalation insulin degludec Pharmaceutical form: solution for injection
Route of administration: subcutaneous |
Active ComparatorAID 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). | Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in HbA1c | Change in glycated hemoglobin (HbA1c) from baseline to end of study | 90 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Events of Level 1 Hypoglycemia (SMBG < 70mg/dL) | Events of hypoglycemia (SMBG \<70 mg/dL for SMBG values more than 30 minutes apart) | 90 days |
Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL) | Events of hypoglycemia (SMBG \<54 mg/dL for SMBG values more than 30 minutes apart) | 90 days |
Events of Severe Hypoglycemia | Events of severe hypoglycemia requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions | 90 days |
Change in Time in Range (Glucose of 70 - 180 mg/dL) | Change from baseline to end of study in Time in Range (TIR), defined as the percentage of time spent with glucose in the range of 70 to 180 mg/dL, based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Change in Time Below Range (Glucose <70 mg/dL) | Change from baseline to end of study in Time Below Range (TBR), defined as the percentage of time spent with glucose \<70 mg/dL, based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Change in Percentage of Time With Glucose <54 mg/dL | Change from baseline to end of study in percentage of time spent with glucose \<54 mg/dL, based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Change in Time Above Range (Glucose >180 mg/dL) | Change from baseline to end of study in Time Above Range (TAR), defined as the percentage of time spent with glucose \>180 mg/dL, based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Change in Percentage of Time With Glucose >250 mg/dL | Change from baseline to end of study in percentage of time spent with glucose \>250 mg/dL, based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Change in Coefficient of Variation (CV) | Change from baseline to end of study in glycemic variability as measured by coefficient of variation (CV), based on continuous glucose monitoring derived glucose values | baseline and 90 days |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Mannkind Corporation5 active studies to exploreNo contact data.
2 Study Locations in 1 Countries
California
Diabetes Treatment Center, Loma Linda University, Loma Linda, California, 92354, United States
Texas
Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States