Trial Outcomes & Findings for Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients (NCT NCT03324776)

NCT ID: NCT03324776

Last Updated: 2024-06-26

Results Overview

Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2024-06-26

Participant Flow

Participant milestones

Measure	Addition of Mealtime Afrezza Inhalation Powder Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm Afrezza Inhalant Product: Mealtime Ultra-Rapid Acting Insulin
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

Baseline characteristics by cohort

Measure	Addition of Mealtime Afrezza Inhalation Powder n=20 Participants Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm
Age, Continuous	61.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Hemoglobin A1c (HbA1c)	9.0 percentage of HbA1c STANDARD_DEVIATION 0.94 • n=5 Participants
Percent of Time Blood glucose (BG) under 70 mg/dL on Continuous Glucose Monitoring System (CGMS)	1.1 percentage of time with glucose <70mg/dL STANDARD_DEVIATION 2.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower

Outcome measures

Measure	Addition of Mealtime Afrezza Inhalation Powder n=20 Participants Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm
Change in Percentage of HbA1c From Baseline to 3 Months	1.6 change in percentage of HbA1c Standard Error 0.247

SECONDARY outcome

Timeframe: 3 months

Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months

Outcome measures

Measure	Addition of Mealtime Afrezza Inhalation Powder n=20 Participants Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm
Percentage of Patients With HbA1c Under 7% at 3 Months	4 Participants

SECONDARY outcome

Timeframe: 3 months

Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.

Outcome measures

Measure	Addition of Mealtime Afrezza Inhalation Powder n=20 Participants Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS	2.6 percent of time with glucose <70mg/dL Standard Deviation 2.5

Adverse Events

Addition of Mealtime Afrezza Inhalation Powder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Levin, MD

MODEL Clinical Research LLC

Phone: 4102413438

Email: pal3420@yahoo.com

Results disclosure agreements

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