Trial Outcomes & Findings for Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study (NCT NCT03143816)

NCT ID: NCT03143816

Last Updated: 2022-02-22

Results Overview

Difference between Time in range for TI group (treatment) and for Aspart group (control)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2022-02-22

Participant Flow

Participant milestones

Measure	Technosphere Insulin (TI, Afrezza) -Treatment Arm There were a total of seven clinic and phone visits during the study period.Patients were randomized 1:1 to TI or insulin aspart group using a blocked design, stratified by screening HbA1c (\<8% or \>8%).All patients used realtime CGM (continuous glucose monitor) during the study period. Patients randomized to aspart continued the same bolus regimen as used before randomization. If patients were using any other RAIA( rapid acting insulin analog) (other than aspart), they were switched to aspart on the same dose at the randomization visit. Patients in the aspart group were also allowed to change their premeal bolus dose and take postprandial and other correction doses as deemed clinically necessary.	Aspart ( Control) There were a total of seven clinic and phone visits during the study period.Patients were randomized 1:1 to TI or insulin aspart group using a blocked design, stratified by screening HbA1c (\<8% or \>8%).All patients used realtime CGM (continuous glucose monitor) during the study period. Patients randomized to aspart continued the same bolus regimen as used before randomization. If patients were using any other RAIA ( rapid acting insulin analog) (other than aspart), they were switched to aspart on the same dose at the randomization visit. Patients in the aspart group were alsoallowed to change their premeal bolus dose and take postprandial and other correction doses as deemed clinically necessary.
Overall Study STARTED	26	34
Overall Study COMPLETED	22	34
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study

Baseline characteristics by cohort

Measure	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=26 Participants This group received Technosphere insulin for bolus insulin with meals and corrections	Insulin Aspart ( Novolog) -Control Arm n=34 Participants This group received insulin aspart for bolus insulin with meals and corrections	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants	34 Participants n=4 Participants	60 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	41 years STANDARD_DEVIATION 16 • n=93 Participants	42 years STANDARD_DEVIATION 14 • n=4 Participants	41 years STANDARD_DEVIATION 15 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	12 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	22 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants	34 Participants n=4 Participants	60 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	26 participants n=93 Participants	34 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks

Difference between Time in range for TI group (treatment) and for Aspart group (control)

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=34 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=22 Participants Group received Technosphere insulin as bolus
Change in Time in Range (%) (70-180 mg/dl) With TI on CGM	53.5 percent time in range Standard Deviation 1.8	58.4 percent time in range Standard Deviation 2.2

SECONDARY outcome

Timeframe: 4 weeks

Difference in postprandial blood glucose between treatment and control group

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI	45 mg/dl Standard Deviation 6	60 mg/dl Standard Deviation 8

SECONDARY outcome

Timeframe: 4 weeks

Difference of glucose variability metrics between treatment and control groups

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)	57.8 mg/dl Standard Deviation 2.4	66.3 mg/dl Standard Deviation 1.9

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4 hours post-dose at 4 weeks

Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration)

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,	15020 min*mg/dl Standard Deviation 560	20020 min*mg/dl Standard Deviation 680

SECONDARY outcome

Timeframe: 4 weeks

Difference in HbA1c between treatment and control group

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
Change in HbA1c (%) in One-month Treatment	0.25 percentage (%) Standard Deviation 0.31	0.02 percentage (%) Standard Deviation 0.36

SECONDARY outcome

Timeframe: 4 weeks

Difference of time above range between treatment and control group

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
Change in Above the Target Time (%) (>180 mg/dl) on CGM	38.1 percent time above target Standard Deviation 0.3	41.2 percent time above target Standard Deviation 1.8

SECONDARY outcome

Timeframe: 4 weeks

Difference of hypoglycemia frequency between treatment and control groups.

Outcome measures

Measure	Insulin Aspart ( Novolog) -Control Arm n=22 Participants Group received insulin aspart as bolus	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=34 Participants Group received Technosphere insulin as bolus
Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM	2.2 percent time below range Standard Deviation 0.7	4.0 percent time below range Standard Deviation 0.6

Adverse Events

Technosphere Insulin (TI, Afrezza) -Treatment Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Insulin Aspart ( Novolog) -Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Technosphere Insulin (TI, Afrezza) -Treatment Arm n=26 participants at risk Group using Technosphere insulin as bolus	Insulin Aspart ( Novolog) -Control Arm n=34 participants at risk Group using insulin aspart as bolus
Respiratory, thoracic and mediastinal disorders mild cough	11.5% 3/26 • Number of events 3 • 5 weeks ( 4 weeks treatment and 1 week follow up) This is a 4-week study, all medications used in this study were FDA approved.	0.00% 0/34 • 5 weeks ( 4 weeks treatment and 1 week follow up) This is a 4-week study, all medications used in this study were FDA approved.

Additional Information

Satish Garg MD

Barbara Davis Center for Diabetes, University of Colorado

Phone: 3037246713

Email: satish.garg@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place