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

NCT05243628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-04-08

Study results available
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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

Interventions

BIOLOGICAL

Afrezza (insulin human) Inhalation Powder

Pharmaceutical form: powder Route of administration: inhalation

BIOLOGICAL

insulin degludec

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DEVICE

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

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Kevin Kaiserman, MD · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-10-17
Completion
2022-10-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243628 on ClinicalTrials.gov