| Trial ID: | L5862 |
| Source ID: | NCT03313960
|
| Associated Drug: |
Afrezza Plus One Drop
|
| Title: |
A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Afrezza plus One Drop | Premium|OTHER: One Drop | Premium
|
| Outcome Measures: |
Primary: Hemoglobin A1c, 3-month between-group change in A1c assessed by a central lab, 3 months | Secondary: Insulin Device Satisfaction, Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS), 3 months|Treatment Adherence, Within- and between-group change in treatment adherence assessed by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) and the Summary of Diabetes Self-care Activities Medications Subscale administered for each oral diabetes medication (SDSCA-MS) and insulin in the regimen (SDSCA-IS)., 3 months|Self-care, Within- and between-group change in self-care assessed by the SDSCA's other subscales, 3 months|Health-related Productivity, Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI)., 3 months|Health-related Quality of Life, Within- and between-group change in health-related quality of life assessed by the Centers for Disease Control Health-related Quality of Life-14 (CDC HRQOL-14) and life satisfaction assessed by the Cantril Self-Anchoring Ladder of Life Satisfaction., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Informed Data Systems, Inc. | Collaborators: Mannkind Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
400
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-05
|
| Completion Date: |
2019-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2019-02-26
|
| Locations: |
One Drop, New York, New York, 10002, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03313960
|
