Trial Outcomes & Findings for Afrezza® Dosing Optimization Study (NCT NCT04849845)
NCT ID: NCT04849845
Last Updated: 2023-09-18
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
120 minutes post-dose
Results posted on
2023-09-18
Participant Flow
Between April 2021 and May 2021, a total of 20 subjects were enrolled at two investigational sites in the US.
Participant milestones
| Measure |
Afrezza
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|
|
Afrezza Dose 1
STARTED
|
20
|
|
Afrezza Dose 1
COMPLETED
|
20
|
|
Afrezza Dose 1
NOT COMPLETED
|
0
|
|
Afrezza Dose 2
STARTED
|
20
|
|
Afrezza Dose 2
COMPLETED
|
20
|
|
Afrezza Dose 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afrezza® Dosing Optimization Study
Baseline characteristics by cohort
| Measure |
Afrezza
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
Afrezza Dose 1: The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
Afrezza Dose 2: The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 13.90 • n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
|
HbA1c
|
6.66 percentage of Hemoglobin A1c
STANDARD_DEVIATION 0.84 • n=39 Participants
|
|
Diabetes type
Type 1 diabetes
|
18 Participants
n=39 Participants
|
|
Diabetes type
Type 2 diabetes
|
2 Participants
n=39 Participants
|
|
BMI
|
26.9 kg/m^2
STANDARD_DEVIATION 6.97 • n=39 Participants
|
PRIMARY outcome
Timeframe: 120 minutes post-dosePopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
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)
Outcome measures
| Measure |
Afrezza Dose 1
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Post-prandial Glucose Excursion
90 minutes PPGE
|
82.8 mg/dL
Standard Error 14.3
|
36.0 mg/dL
Standard Error 10.2
|
|
Post-prandial Glucose Excursion
15 minutes PPGE
|
6.8 mg/dL
Standard Error 3.3
|
5.6 mg/dL
Standard Error 2.5
|
|
Post-prandial Glucose Excursion
30 minutes PPGE
|
25.9 mg/dL
Standard Error 5.7
|
21.9 mg/dL
Standard Error 5.6
|
|
Post-prandial Glucose Excursion
45 minutes PPGE
|
48.9 mg/dL
Standard Error 6.9
|
27.0 mg/dL
Standard Error 6.6
|
|
Post-prandial Glucose Excursion
60 minutes PPGE
|
64.2 mg/dL
Standard Error 7.9
|
34.3 mg/dL
Standard Error 8.1
|
|
Post-prandial Glucose Excursion
120 minutes PPGE
|
88.6 mg/dL
Standard Error 17.7
|
36.9 mg/dL
Standard Error 13.1
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Number of subjects with at least 1 event (also referred to as incidence) of Level 1 hypoglycemia (\<70mg/dL) within the 120 minutes after Afrezza dosing as confirmed by SMBG.
Outcome measures
| Measure |
Afrezza Dose 1
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Number of Subjects With at Least 1 Event of Level 1 Hypoglycemia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Percent of total SMBG measurements \<70 mg/dL (Level 1 hypoglycemia) within the 120 minutes after Afrezza dosing.
Outcome measures
| Measure |
Afrezza Dose 1
n=120 SMBG Measurements
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=120 SMBG Measurements
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Percent of Level 1 Hypoglycemia
|
0 SMBG Measurements
|
2 SMBG Measurements
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Number of subjects with at least 1 event (also referred to as incidence) of Level 2 hypoglycemia (\<54mg/dL) within the 120 minutes after Afrezza dosing as confirmed by SMBG.
Outcome measures
| Measure |
Afrezza Dose 1
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Number of Subjects With at Least 1 Event of Level 2 Hypoglycemia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Percent of total SMBG measurements \<54 mg/dL (Level 2 hypoglycemia) within the 120 minutes after Afrezza dosing
Outcome measures
| Measure |
Afrezza Dose 1
n=120 SMBG Measurements
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=120 SMBG Measurements
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Percent of Level 2 Hypoglycemia
|
0 SMBG Measurements
|
1 SMBG Measurements
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Number of subjects with at least 1 event (also referred to as incidence) of severe hypoglycemia, defined as events requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions within the 120 minutes after Afrezza dosing.
Outcome measures
| Measure |
Afrezza Dose 1
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Number of Subjects With At Least 1 Event of Severe Hypoglycemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 minutes post-dosePopulation: Intent to treat, including all subjects in the safety population, had a baseline value and at least one postbaseline value
Change in percent predicted forced expiratory volume in 1 second (FEV1) between two points (value at 120 minutes post-Afrezza dose minus value at baseline). Standard deviation was not reported.
Outcome measures
| Measure |
Afrezza Dose 1
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 Participants
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Between Two Points, Baseline and 120 Minutes Post-Afrezza Dose
|
0.63 change in percent predicted FEV1
Standard Deviation 8.25
|
-2.55 change in percent predicted FEV1
Standard Deviation 5.78
|
Adverse Events
Afrezza Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Afrezza Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afrezza Dose 1
n=20 participants at risk
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The first dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
|
Afrezza Dose 2
n=20 participants at risk
The test product was defined as Afrezza \[insulin human\] inhalation powder administered using the Afrezza inhaler. In addition, subjects took their personal basal insulin while enrolled in the study.
The second dose of Afrezza was based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Duration of the two treatment visits (~8 hours)
|
10.0%
2/20 • Number of events 2 • Duration of the two treatment visits (~8 hours)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose any of the results arising out of or in connection with the clinical trial without the prior express written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER