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NCT04849845 · ClinicalTrials.gov registry record · Phase 4
Afrezza® Dosing Optimization Study
A Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT04849845: Completed Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.
NCT04849845 is a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1 that has completed, run by Mannkind Corporation. The registered enrollment target is 20 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04849845, a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, has completed, sponsored by Mannkind Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated dose, in combination with a basal insulin in adult subjects (≥18 years of age) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Eligible subjects will be on a stable regimen consisting of a basal bolus insulin therapy prior to screening. The study is composed of up to 4 clinic visits (screening, 2 treatment visits, and a follow-up visit). Two individual doses of Afrezza will be administered during a meal challenge at Visits 2 and 3. The duration of each subject's participation in the trial is expected to be approximately 2 weeks.
Primary Outcome
Mean glucose change from baseline (or postprandial glucose excursion \[PPGE\]) based on self-monitored blood glucose (SMBG) at 15, 30, 45, 60, 90 and 120 minutes after the dose of Afrezza with baseline defined as SMBG at the time of the dose of Afrezza (t=0)
Conditions Studied
Interventions
- COMBINATION_PRODUCT Afrezza Dose 1
- COMBINATION_PRODUCT Afrezza Dose 2
Study Locations (2)
California
- AMCR Institute - Escondido
- Diablo Clinical Research - Walnut Creek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 4 |
What the finished NCT04849845 record still lists
NCT04849845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Afrezza Dose 1 is the first listed.
NCT04849845 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04849845 about?
NCT04849845 is a clinical study titled "Afrezza® Dosing Optimization Study". MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated dose, in combination with a basal insulin in adult subjects (≥18 years of...
What is the current status of trial NCT04849845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2021-04-09. Estimated completion is 2021-05-28.
What conditions does trial NCT04849845 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT04849845?
The interventions under investigation include: Afrezza Dose 1 (COMBINATION_PRODUCT), Afrezza Dose 2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04849845?
This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04849845 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04849845's enrollment target sits among peer trials
20 324th of 348 higher than 20 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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