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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04849845
The ClinicalTrials.gov registry entry for NCT04849845 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The listed sponsor is Mannkind Corporation, which has 42 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.