Afrezza-OneDrop Controlled Trial (A-One) Now Fully Enrolled

[mnholdem]

Source: clinicaltrials.gov/ct2/show/NCT03313960?term=MANNKIND&recrs=abdfg&rank=4

ClinicalTrials.gov Identifier: NCT03313960

Recruitment Status : Active, not recruiting
First Posted : October 19, 2017

Last Update Posted : June 1, 2018

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Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A-One: A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

Actual Study Start Date: October 5, 2017
Estimated Primary Completion Date: September 30, 2018
Estimated Study Completion Date: September 30, 2019

Primary Outcome Measures

1. Hemoglobin A1c [ Time Frame: 3 months ]

Secondary Outcome Measures

1. Insulin Device Satisfaction [ Time Frame: 3 months ] assessed by the Insulin Device Satisfaction Survey (IDSS);
2. Treatment Adherence [ Time Frame: 3 months ] assessed by ARMS-D*, SDSCA-MS* and SDSCA-IS*;
3. Self-care [ Time Frame: 3 months ] assessed by the SDSCA's other subscales;
4. Health-related Productivity [ Time Frame: 3 months ] assessed by the Work Productivity and Activity Impairment measure (WPAI);
5. Health-related Quality of Life [ Time Frame: 3 months ] assessed by CDC HRQOL-14* and the Cantril Self-Anchoring Ladder of Life Satisfaction.

*Acronyms

ARMS-D = Adherence to Refills and Medications Scale for Diabetes

SDSCA-MS = Summary of Diabetes Self-care Activities Medications Subscale administered for each oral diabetes medication

SDSCA-IS = Summary of Diabetes Self-care Activities Medications Subscale administered for  insulin in the regimen
CDC HRQOL-14 = Centers for Disease Control Health-related Quality of Life-14

[dh4mizzou]

So what's the difference between the Estimated Primary Completion Date and the Estimated Study Completion Date?

And don't tell me one year ;-)

[mnholdem]

The Primary Outcome: Hemoglobin A1c [3-month between-group change in A1c assessed by a central lab] on track to be completed by 4th Quarter 2018.

There has been a fairly robust debate among ProBoards-MNKD members about endocrinologists and PCP's currently using A1c as the standard measurement to assess patients with diabetes mellitus. As the adoption and acceptance of Continuous Glucose Monitoring (CGM) among the diabetes medical community grows, new measurement standards will be forthcoming.

"A majority of the speakers were excited about the progress being made in standardizing glycemic outcomes beyond A1c, such as defining the blood glucose ranges associated with time-in-range (and out-of-range), instances of hypoglycemia or hyperglycemia, and other metrics related to CGM." - July 22, 2017 report of the “Glycemic Outcomes Beyond A1c: Standardization and Implementation” gathering of leaders in the diabetes community. diatribe.org/measuringwhatmatters

Science is rapidly progressing and, with CGM and other new technologies ushering in a new age for better control of diabetes, new measurement standards will be adopted by the diabetes community. Still, A1c remains the predominant measurement by which endocrinologists, primary care physicians and other healthcare professional measure the health of patients with diabetes mellitus.

The A-ONE trial will present data on both the current A1c standard of measurement (arguably adhered to by most HCPs) and future standards of measurement and provide empirical evidence on the health benefits of Afrezza inhaled insulin, focusing on effective treatment and quality of life issues for patients with Type 2 diabetes.

The science will prevail.

[mnholdem]

Jun 7, 2018 7:22:10 GMT -5 dh4mizzou said:

So what's the difference between the Estimated Primary Completion Date and the Estimated Study Completion Date?

And don't tell me one year ;-)

The first is the date by which clinical trial data related to the Primary Outcome Measures will be collected for analysis. By the Study Completion Date, clinical trial data related to all the remaining Secondary Outcome Measures will be ready for analysis.