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

NCT05243628 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: MKC-TI-192
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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

Conditions

Type 1 Diabetes

Keywords

Diabetes Mellitus; Insulin; Inhaled Insulin; Afrezza; Technosphere Insulin

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

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

  90 days

Secondary Outcomes (9)

• 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

Other Outcomes (5)

• Change in Percent Predicted Forced Expiratory Volume in 1 Second

  baseline and 90 days

• Total Number of Treatment-Emergent Adverse Events

  90 days

• Total Number of Serious Adverse Events

  90 days

Study Arms (3)

Afrezza + Automatic Insulin Delivery

EXPERIMENTAL

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.

Biological: Afrezza (insulin human) Inhalation Powder; Device: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)

Afrezza + Insulin Degludec

EXPERIMENTAL

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

Biological: Afrezza (insulin human) Inhalation Powder; Biological: insulin degludec

AID Control

ACTIVE COMPARATOR

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).

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

Interventions

Afrezza (insulin human) Inhalation Powder BIOLOGICAL

Pharmaceutical form: powder Route of administration: inhalation

Also known as: Technosphere Insulin

Afrezza + Automatic Insulin Delivery; Afrezza + Insulin Degludec

insulin degludec BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: Tresiba

Afrezza + Insulin Degludec

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

AID Control; Afrezza + Automatic Insulin Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (2)

Diabetes Treatment Center, Loma Linda University

Loma Linda, California, 92354, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Related Publications (1)

• 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.

  PMID: 40531276 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin; insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limitations of the study include its open-label and non-controlled study design and a small sample size (Total Started=28).

Results Point of Contact

• Title: Jennifer Pleitez, Director of Clinical Operations
• Organization: Mannkind Corporation

endocrineresearch@mannkindcorp.com

818-661-5032

Study Officials

• Kevin Kaiserman, MD

  Mannkind Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: March 31, 2022
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: April 8, 2025
• Results First Posted: October 18, 2024

Record last verified: 2025-03

Locations

US (2)