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Type 1 DiabetesPhase 4ABCNCT05243628

Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes

A Phase 4 study testing Afrezza (insulin human) Inhalation Powder, insulin degludec and Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) in people with Type 1 Diabetes, run by Mannkind Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Afrezza (insulin human) Inhalation Powder, insulin degludec and Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
31 Mar 2022to 17 Oct 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731

  • Diabetes Treatment Center, Loma Linda University

    Loma Linda, California, 92354

Other trials in United States

About this study

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

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

Read the 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 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.

Conditions
Type 1 Diabetes
Being tested
Afrezza (insulin human) Inhalation Powder, insulin degludec, Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)
Keywords
Diabetes Mellitus, Insulin, Inhaled Insulin, Afrezza, Technosphere Insulin
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Afrezza (insulin human) Inhalation PowderBiological

    Also called Technosphere Insulin

    Pharmaceutical form: powder

    Route of administration: inhalation

  • insulin degludecBiological

    Also called Tresiba

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)Device

    Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ

Study groups in NCT05243628
Study groupRoleWhat they receive
Afrezza + Automatic Insulin DeliveryExperimentalSubjects 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.
Receives: Biological: Afrezza (insulin human) Inhalation Powder; Device: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)
Afrezza + Insulin DegludecExperimentalSubjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
Receives: Biological: Afrezza (insulin human) Inhalation Powder; Biological: insulin degludec
AID ControlActive comparatorSubjects 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).
Receives: Device: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in glycated hemoglobin (HbA1c) from baseline to end of study

    Measured: 90 days

Secondary outcomes (9)

  1. Events of Level 1 Hypoglycemia (SMBG < 70mg/dL)

    Events of hypoglycemia (SMBG <70 mg/dL for SMBG values more than 30 minutes apart)

    Measured: 90 days

  2. Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL)

    Events of hypoglycemia (SMBG <54 mg/dL for SMBG values more than 30 minutes apart)

    Measured: 90 days

  3. Events of Severe Hypoglycemia

    Events of severe hypoglycemia requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

    Measured: 90 days

  4. 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

    Measured: baseline and 90 days

  5. 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

    Measured: baseline and 90 days

  6. 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

    Measured: baseline and 90 days

  7. 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

    Measured: baseline and 90 days

  8. 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

    Measured: baseline and 90 days

  9. 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

    Measured: baseline and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start31 Mar 2022
  3. Primary completion17 Oct 2022
  4. Study completion17 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243628
Sponsor's protocol ID
MKC-TI-192
Acronym
ABC
Status last verified
Mar 2025
First submitted
7 Feb 2022
Last updated
8 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Jacobson C, Kaiserman KB, Ulloa J, Pleitez J, Sylvan J, Rinker J, Codorniz K, Lee S, Vakhshoori M, Lobo Moreno P, Blevins T. Safety and Efficacy of Inhaled Technosphere(R) Insulin in the Postprandial Period With Modified Initial Dose Conversion. Diabetes Ther. 2025 Aug;16(8):1695-1705. doi: 10.1007/s13300-025-01760-5. Epub 2025 Jun 18.

    PubMed 40531276

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Afrezza (insulin human) Inhalation Powder, insulin degludec and Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) in people with Type 1 Diabetes, run by Mannkind Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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ABC Clinical Trial NCT05243628 | AzTrials