Status:
UNKNOWN
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
Lead Sponsor:
Diabetes and Glandular Disease Clinic
Collaborating Sponsors:
Mannkind Corporation
DexCom, Inc.
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezz...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
- Screening A1c 7.5 % - 11.5% inclusive
- Willing and able to wear CGM system during the study
- Willing to use only inhaled insulin (Afrezza®) at meals and for correction
- Able to understand, speak, read and write English
- Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy
Exclusion
- Diagnosed with COPD
- Is an active smoker , or has smoked in the past 6 months
- Diagnosed with asthma
- Pregnancy, breast-feeding or planning to become pregnant during study period
- Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
- Use of oral or injected corticosteroid within 6 weeks of study enrollment
- Enrollment in another investigational trial at the time of screening
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04125082
Start Date
February 27 2019
End Date
March 15 2020
Last Update
January 30 2020
Active Locations (1)
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1
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229