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

NCT ID: NCT05243628

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-10-17

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Afrezza (insulin human) Inhalation Powder

Intervention Type: BIOLOGICAL

Pharmaceutical form: powder

Route of administration: inhalation

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

Intervention Type: DEVICE

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

Afrezza + Insulin Degludec

Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.

Group Type: EXPERIMENTAL

Afrezza (insulin human) Inhalation Powder

Intervention Type: BIOLOGICAL

Pharmaceutical form: powder

Route of administration: inhalation

insulin degludec

Intervention Type: BIOLOGICAL

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

Afrezza (insulin human) Inhalation Powder

Pharmaceutical form: powder

Route of administration: inhalation

Intervention Type: BIOLOGICAL

insulin degludec

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type: BIOLOGICAL

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

Intervention Type: DEVICE

Other Intervention Names

Technosphere Insulin; Tresiba

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Kaiserman, MD

Role: STUDY_DIRECTOR

Mannkind Corporation

Locations

Diabetes Treatment Center, Loma Linda University

Loma Linda, California, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40531276 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MKC-TI-192

Identifier Type: -

Identifier Source: org_study_id