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NCT03313960

A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

Status unknown Phase 4 Last updated 26 February 2019
What this trial tests

Phase 4 trial testing Afrezza plus One Drop | Premium in Diabetes Mellitus, Type 2 in 400 participants. Status unknown.

Timeline
5 October 2017
Primary endpoint
30 September 2018
30 December 2019

Quick facts

Lead sponsorInformed Data Systems, Inc.
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment400
Start date5 October 2017
Primary completion30 September 2018
Estimated completion30 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Informed Data Systems, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop \| Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) \> 7.0% already prescribed an injectable rapid-acting insulin.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03313960.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing