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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Mannkind Corporation
Study ID
NCT05243628
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afrezza (insulin human) Inhalation Powder — BIOLOGICAL
    Pharmaceutical form: powder Route of administration: inhalation
  • insulin degludec — BIOLOGICAL
    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 Details

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

Key Dates

First listed
Feb 17, 2022
Start date
Mar 31, 2022
Status verified
Mar 2025
Primary completion
Oct 17, 2022
Completion
Oct 17, 2022

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: Afrezza + Insulin Degludec
    Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
  • Active Comparator: 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).

Primary Outcome Measure

Change in HbA1c [ Time Frame: 90 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Diabetes Treatment Center, Loma Linda UniversityLoma LindaCalifornia92354-
Texas Diabetes and EndocrinologyAustinTexas78731-

Find similar trials in Loma Linda, CA

Nationwide
Type 1 diabetes trialsEndocrinology trials
By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Diabetes Treatment Center, Loma Linda University· Loma Linda, CATexas Diabetes and Endocrinology· Austin, TX

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